Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Antibodies

Pemetrexed

Immunoglobulins

Patients with unresectable NSCLC will receive 3-4 cycles of serplulimab plus chemotherapy as the conversion treatment (serplulimab 300mg d1 q3w; carboplatin (AUC 5) on day 1, and pemetrexed (500 mg/m2 for adenocar- cinoma) or nab-paclitaxel (260 mg/m2 for squamous carcinoma) d1 q3w), and then curative pneumonectomy will be provided for patients who are suitable for primary tumor resection. Locoregional ablative treatments will be performed for metastatic lesions. Maintenance treatment with PD-1 antibody q3w will continue up to 12 months or disease progression after surgery.

Patients with unresectable NSCLC will receive serplulimab plus chemotherapy as conversion treatment, and then curative pneumonectomy will be provided for patients who are suitable for primary tumor resection. Locoregional ablative treatments will be performed for metastatic lesions.

serplulimab plus chemotherapy as conversion treatment

Peng Zhao, MD

Jian Hu, MD

Lulu Liu

Weijia Fang, MD

This is a phase II, single-arm study to evaluate the efficacy and safety of Serplulimab plus chemotherapy as conversion treatment in patients with stage IIIB-IVA oligometastatic non-small cell lung cancer.

This single-arm, open-label, prospective phase II clinical trial was designed to evaluate the efficacy and safety of Serplulimab plus chemotherapy as conversion treatment in patients with stage IIIB-IVA oligometastatic non-small cell lung cancer.

The primary endpoints were the rate of NSCLC converting to resectable tumors and the 1-year progression-free survival (PFS) rate.The secondary endpoints included the rates of R0 resection, major pathological response (MPR) and pathological complete response (pCR), overall survival (OS) and PFS. Multi-omics analysis will be performed to identify potential biomarkers for treatment response.

A Phase II Trial to Evaluate the Efficiency and Safety of Serplulimab Plus Chemotherapy as Conversion Therapy in NSCLC

A Phase II Trial to Evaluate the Efficiency and Safety of Serplulimab Plus Chemotherapy as Conversion Treatment for Patients With Stage IIIB-IVA Oligometastatic Non-small Cell Lung Cancer

the proportion of unresectable NSCLC patients who are converted to being suitable for radical pneumonectomy after 3-4 cycles serplulimab plus chemotherapy

the proportion of patients who are progression-free after pneumonectomy

the proportion of R0 resection in patients who receive pneumonectomy

The duration from the date of initial treatment to the date of disease progression or death due to any cause

The duration from the date of initial treatment to the date of death due to any cause

the proportion of patients who achieve MRP among those receiving pneumonectomy

the proportion of patients who achieve pCR among those receiving pneumonectomy

Zhejiang University

Professor

Micronutrients

Hematinics

Vitamins

Vinorelbine

Cisplatin

Immunomodulating Agents

Durvalumab

Antibodies, Monoclonal

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Antineoplastic Agents, Immunological

Immunologic Factors

Tubulin Modulators

Antimitotic Agents

Folinic Acid

Folate

Vitamin B9

Treatment plan:

* Part 1: induction with durvalumab plus histology-based chemotherapy regimen.
* Part 2: patients with a sufficient tumor shrinkage to be considered eligible for part 2 and they will be treated concomitantly with durvalumab and radiotherapy.
* Part 3: patients with partial response or stable disease after part 2 will be eligible for durvalumab maintenance, for up to 2 years or until disease progression or unacceptable toxicity.

Induction therapy: durvalumab plus histology-based chemotherapy regimen (cisplatin or carboplatin plus vinorelbine for squamous histology and pemetrexed for non-squamous histology).

durvalumab plus platinum-based chemotherapy (cisplatin or carboplatin plus vinorelbine or pemetrexed)

Durvalumab plus radiotherapy

durvalumab

Valter Torri

Roberto Ferrara

Standard treatment for stage III Non-Small Cells Lung Cancer (NSCLC) not eligibile for surgery is concomitant chemoradiotherapy. However median progression free survival and overall survival is still poor with only 15% of patients alive at 5 years. The addition of maintenance therapy with durvalumab after chemoradiation showed a significant benefit in PFS and OS, with good tolerability and no concerns in terms of safety. However, about 30% of patients with stage III are not eligible to concurrent chemoradiotherapy because of large volumes of the tumor. To date, these patients are initially treated with chemotherapy with the aim of reducing tumor volumes and allowing sequential radiotherapy. Response rate ranges between 25-30% and majority of patients will not become suitable for radiotherapy.

The combination of immunotherapy plus standard chemotherapy in advanced stages doubles response rates and provides major tumor shrinkage compared to standard chemotherapy alone. For these reasons, the investigators want to exploit the synergistic effect of immunotherapy combined with chemotherapy in the induction phase, in order to render suitable for radiotherapy a larger number of patients, and in a second phase the synergistic effect with radiotherapy.

Based on these premises the investigators designed a single arm, phase 2 trial to determine the efficacy and safety of combining immunotherapy with the drug durvalumab in association with standard chemotherapy and subsequently with standard radiotherapy, followed by a treatment of maintenance with only durvalumab.

The study population includes patients with NSCLC not eligible for surgery or concurrent chemoradiation at diagnosis because of large tumor volumes.

BRIDGE trial aims to evaluate the proportion of patients who did not progress and who achieved a mean lung dose \<20 Gy and/or a lung V20\<35% (response) after part 1. The primary objective of the study is to increase the proportion of patients eligible for immunotherapy plus radiotherapy after induction with durvalumab and chemotherapy, in comparison with historical controls.

This study will last approximately 60 months and will include approximately 65 eligible patients in 3 international cancer centres of excellence.

Standard treatment for stage III Non-Small Cells Lung Cancer (NSCLC) not eligibile for surgery is concomitant chemoradiotherapy. However median progression free survival and overall survival is still poor with only 15% of patients alive at 5 years. The addition of maintenance therapy with durvalumab after chemoradiation showed a significant benefit in PFS and OS, with good tolerability and no concerns in terms of safety. However, about 30% of patients with stage III are not eligible to concurrent chemoradiotherapy because of large volumes of the tumor. To date, these patients are initially treated with chemotherapy with the aim of reducing tumor volumes and allowing sequential radiotherapy. Response rate ranges between 25-30% and majority of patients will not become suitable for radiotherapy.

The combination of immunotherapy plus standard chemotherapy in advanced stages doubles response rates and provides major tumor shrinkage compared to standard chemotherapy alone. For these reasons, the investigators want to exploit the synergistic effect of immunotherapy combined with chemotherapy in the induction phase, in order to render suitable for radiotherapy a larger number of patients, and in a second phase the synergistic effect with radiotherapy.

Based on these premises the investigators designed a single arm, phase 2 trial to determine the efficacy and safety of combining immunotherapy with the drug durvalumab in association with standard chemotherapy and subsequently with standard radiotherapy, followed by a treatment of maintenance with only durvalumab.

The study population includes patients with NSCLC not eligible for surgery or concurrent chemoradiation at diagnosis because of large tumor volumes.

The study consists of 3 parts:

* Part 1: induction with durvalumab plus chemotherapy.
* Part 2: patients with a sufficient tumor shrinkage to be considered eligible for part 2 and they will be treated concomitantly with durvalumab and radiotherapy.
* Part 3: patients with partial response or stable disease after part 2 will be eligible for durvalumab maintenance, for up to 2 years or until disease progression or unacceptable toxicity.

BRIDGE trial aims to evaluate the proportion of patients who did not progress and who achieved a mean lung dose \<20 Gy and/or a lung V20\<35% (response) after part 1. The primary objective of the study is to increase the proportion of patients eligible for immunotherapy plus radiotherapy after induction with durvalumab and chemotherapy, in comparison with historical controls.

This study will last approximately 60 months and will include approximately 65 eligible patients in 3 international cancer centres of excellence.

multicentric, open label, single arm, minimax Simon 2 stages, phase 2 trial

Durvalumab and Chemotherapy Induction Followed by Durvalumab and Radiotherapy in Large Volume Stage III NSCLC

BRIDGE Trial: Phase II Trial of durvalumaB and chemotheRapy Induction Followed by Durvalumab and Radiotherapy in larGe volumE Stage III NSCLC

To evaluate the concordance between patients who reach the primary endpoint and patients who are included in part 2 after the evaluation of the multidisciplinary team

To evaluate correlation of clinical outcome with PD-L1 expression (in percentage %).

Plasma for cfDNA will be analyzed through whole exome sequencing (considering coding region only) to assess correlation with response.

To assess the dynamic changes of the tumor mutational profile upon different treatment time points.

The primary objective of the study is to increase the proportion of patients eligible for immunotherapy plus radiotherapy after induction with durvalumab and chemotherapy, in comparison to historical controls.

PFS is defined as the time from the date of start of induction treatment until the date of objective disease progression or death to any cause whichever comes first. PFS will be evaluated using RECIST 1.1 criteria according to investigators and blinded central review (BCR).

To evaluate Objective Response Rate (ORR) of each phase of treatment and the overall response rate. ORR is defined as the proportion of patients with complete or partial response (as best response) according to RECIST 1.1 as assessed by Investigators and BCR.

OS is defined as the time from the date of start of induction treatment until death due to any cause. Patients alive at the time of statistical analysis will be censored at their last information on vital status.

The assessment of safety will be mainly based on adverse reactions (ARs) and the frequency and nature of SAEs. Toxicity and safety will be evaluated during each part of the program, throughout study duration.

AstraZeneca

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Mario Negri Institute for Pharmacological Research

GFH018 80mg 7-Day on/ 7-Day off and 4 doses of Toripalimab 240mg Q3W concurrently with standard chemo-radiotherapy, followed by GFH018 80mg 14-Day on/ 14-Day off and Toripalimab 3mg/kg Q2W for up to 48 weeks

GFH018

Toripalimab

Thoracic Radiation Therapy (TRT)

This is a phase II trial assessing the efficacy and safety of GFH018 and Toripalimab in combination with concurrent chemoradiotherapy (cCRT) in patients with unresectable, locally advanced, Stage III non-small cell lung cancer (NSCLC).

A Trial of GFH018 and Toripalimab in Combination With Concurrent Chemoradiotherapy in Stage III NSCLC Chemoradiotherapy in Stage III NSCLC

A Phase 2 Trial of GFH018 and Toripalimab in Combination With Concurrent Chemoradiotherapy for Patients With Unresectable, Locally Advanced Stage III Non-Small Cell Lung Cancer (NSCLC)

Objective response rate (ORR) is defined as the percentage of patients with objective response (OR).

OR was determined using the Response Evaluation Criteria in Solid Tumors (RECIST v1.1). OR is defined as the best overall response (Complete Response (disappearance of all target and non-target lesions; no new lesions) or Partial Response (≥decrease in the sum of the largest diameters of target lesions; no new lesions)) across all assessment points from enrollment to termination of trial treatment. Radiological tumour assessment was performed using CT scans.

Zhejiang Genfleet Therapeutics Co., Ltd.

All participants included in the study will receive a starting dose of 6 mg/kg of DS-1062a every 3 weeks until progression or until unacceptable toxicity

First infusion for 90 minutes and then infusion duration can be decreased to 30 minutes if participant didn't experience infusion related reactions (IRR)

DS-1062a

Babara Pistili, Dr

Fernanda Fernanda, Dr

Barbara Pistilli, Dr

Ghada Nachabeh, PM

This study aims to evaluate the efficacy and safety of DS-1062a in participants with metastatic, unresectable NSCLC having progressed on one, but not more than three previous standard therapies. Moreover, the immune effects, the predictors of resistance and response to treatment, the effect of the chemotherapy on deoxyribonucleic acid (DNA) replication will be assessed and will help identify the subgroups that will mostly benefit from the treatment. The pharmacokinetics of the product and the anti-drug antibody (ADA) will be also evaluated.

A total of 100 participants are planned to be included in the study. Participants will receive, every three weeks, a dose of DS-1062a equivalent to 6 mg/kg of body weight until progression or until unacceptable toxicity.

Tumor evaluation will be performed every six weeks by the mean of a computed tomography for the thorax, abdomen and pelvis (TAP CT-scan) or a magnetic resonance imaging (MRI). Brain and/or bone CT scans will be also performed throughout the study for participants with brain and/or bone metastasis.

The safety of the product will be assessed at each cycle, through complete clinical exams, biological tests, electrocardiograms (ECGs), cardiac echographies (ECHOs) and through the collection of ongoing toxicities or adverse events.

One group of 100 participants receiving DS-102a

Datopotamab (DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer

Phase 2, Open Label Study of DS-1062a, an Anti-TROP-2-Antibody-Drug Conjugate (ADC), in Patients With Advanced and/or Unresectable Non-Small Cell Lung Cancer (NSCLC), With Biomarker Analysis to Characterize Response to Therapy

ORR is defined as the proportion of participants who achieved a confirmed complete response (CR) or partial response (PR) observed on treatment and assessed by investigators

Defined as the time from the first documented CR or PR until the date of disease progression, or until the date of death

Defined as the time date of the first dose until progression or death from any cause, whichever occurs first

Defined as the presence of at least a PR or CR, or a stable disease (SD) for more than six months under treatment

All adverse events (AEs), treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse events of special interest (AESIs)

Treatment discontinuation, interruptions and dose reductions

Daiichi Sankyo

Gustave Roussy, Cancer Campus, Grand Paris

Radiation Therapy - Phase I: 45 Gy at 3 Gy per fractions once a day.

Phase II: 45 Gy at 3 Gy per fraction once a day or 66-70 Gy at 2 Gy per fraction once a day.

ZD6474 (ZACTIMA) beginning at 100 mg once a day by mouth.

ZD6474 (ZACTIMA) beginning at 100 mg once a day by mouth

ZD6474 (ZACTIMA)

Phase I: 45 Gy at 3 Gy per fractions once a day.

Phase II: 45 Gy at 3 Gy per fraction once a day or 66-70 Gy at 2 Gy per fraction once a day.

Radiation Therapy

Melenda D. Jeter, MD, MPH

Primary Objectives:

* To assess the safety of oral therapy with ZD6474 by evaluating the frequency, severity, and duration of treatment-emergent adverse events in patients with poor prognosis lung cancer.
* To record the extent, frequency and duration of any tumor responses to this treatment regimen and assess whether ZD6474 augments the efficacy of radiation therapy in non-small cell lung cancer patients.
* To determine the recommended phase II dose of ZD6474 for future clinical studies with radiation therapy.

Secondary Objectives:

* To determine the effects on metabolism and angiogenic factors by positron emission tomography (PET) scan/computed tomography (CT) scan , vascular endothelial growth factor (VEGF), and circulating endothelial cell levels in patients treated with ZD6474 and radiation therapy.

ZD6474 is a new drug that is thought to block the formation of new blood vessels. The growth of new blood vessels is called angiogenesis. Angiogenesis is thought to be essential for the growth of tumors beyond a small size.

Before treatment starts, you will have several tests and procedures performed. These tests will include a complete medical history and physical exam, including recent weight loss, vital signs, and a test to check how easily you swallow. Laboratory tests needed will require a urine sample, and blood samples (about 3-4 teaspoons). Women who are able to have children must have a negative blood pregnancy test in order to participate in this study. You will have an electrocardiogram (ECG--a test to measure the electrical activity of the heart), heart function tests, and scans of your brain, chest, and bones. You will also have PET scans performed.

You may take part in this study if you are a patient with NSCLC who is not able to receive chemotherapy.

If you are eligible to participate, you will receive ZD6474 by mouth once a day every day, along with radiation therapy. You must take your medication on an empty stomach, at approximately the same time each morning. ZD6474 should be swallowed as a whole tablet (not chewed, crushed or divided) and taken with 8 oz of water. Missed doses may be taken by the end of the same calendar day. However, if a subject misses taking their scheduled dose on the same day, he or she must take the next scheduled dose and the missed dose will not be made up. The missed dose must be documented on patients medication diary ZD6474 will be given 5-7 days before starting radiation therapy and will continue through the entire course of radiation therapy, unless there is proof that the cancer is progressing. ZD6474 may interact with many commonly prescribed medications. A list will be provided to you.

Radiation will be given every weekday (Monday - Friday) for 3-7 weeks as your doctor thinks is necessary and useful. You will have weekly evaluations during radiation treatment, including blood samples (3-4 teaspoons) for routine testing, oxygen saturation (a test that measures how much oxygen is in the blood), and physical examination.

If you need anti-nausea medication (such as Zofran) during this study, you will have an ECG performed within 24 hours of starting the medication and then again at least once a week while you remain on the medication.

You will continue on study, unless there is evidence that the disease has gotten worse or intolerable side effects occur.

You will be seen for a follow-up visit one month after completing radiation therapy, and again at 3 months. You will then come in for a follow-up visit every 3 months for 2 years, then every 6 months for 3 years, then once a year. Scheduled tests and follow-ups should be performed within 1 week (before or after) of the scheduled time period (a 14-day window). At these visits, you will have blood draws (about 3-4 teaspoons), urine tests and x-rays. You will have an ECG, lung function tests, and PET/CT scans.

Participants who are blood donors should not donate blood during the study and for 3 months following their last dose of study treatment.

This is an investigational study. ZD6474 is not FDA approved, and has been authorized for research only. A total of up to 48 patients will take part in this study. All patients will be enrolled at UT MD Anderson Cancer Center (MDACC).

Radiation Therapy (XRT) and ZD6474 in Non-Small Cell Lung Cancer (NSCLC)

A Phase I Dose-Escalation and Safety Study of ZD6474 (ZACTIMA) Used In Combination With Radiation Therapy for Patients With Inoperable/Unresectable Non-Small Cell Lung Cancer

M.D. Anderson Cancer Center

Etoposide

Nivolumab

Ipilimumab

Etoposide phosphate

Immune Checkpoint Inhibitors

Thoracic Radiotherapy with cytotoxic platinum based chemotherapy with cytotoxic platinum based chemotherapy including cisplatin and etoposide, carboplatin and paclitaxel or cisplatin and pemetrexed (for patients with non-squamous histology) and Ipilimumab.

Nivolumab 480 mg (30 minute IV infusion) after completion of radiation and chemotherapy for up to 12 cycles until progression.

2 Gy in 30 fractions directed at all sites of suspected disease

Thoracic Radiotherapy

Platinum based chemotherapy including cisplatin and etoposide, carboplatin and paclitaxel or cisplatin and pemetrexed (for patients with non-squamous histology).

Platinum Based Chemotherapy

ipilimumab 1mg/kg delivered concurrently with initiation of chemoradiotherapy and in week 4 of chemoradiotherapy

ipilimumab

Nivolumab 480 mg (30 minute IV infusion) at least 7 days but no more than 21 days after completion of radiation and chemotherapy every 4 weeks for up to 12 cycles.

Bradford Perez, MD

This study is to determine if Stage III NSCLC patients treated with ipilimumab with thoracic radiation therapy followed by nivolumab monotherapy every 4 weeks for up to 12 months show an improved 12-month Progression Free Survival (PFS) rate compared with a 12-month historical PFS rate of 49% among patients treated in a similar fashion with concurrent chemoradiotherapy.

Radiation and Chemotherapy With Ipilimumab Followed by Nivolumab for Patients With Stage III Unresectable Non-Small Cell Lung Cancer (NSCLC)

Radiation and Chemotherapy With Ipilimumab Followed by Nivolumab for Patients With Stage III Unresectable NSCLC

Unacceptable toxicity defined as:

* Any grade 4 immune related adverse event (irAE)
* Any grade 3 irAE, excluding pneumonitis, that does not downgrade to grade 2 within 7 days after onset of the event despite optimal medical management including systemic corticosteroids or does not downgrade to ≤ grade 1 or baseline within 14 days
* Liver transaminase elevation \> 8 × ULN or total bilirubin \> 5 × ULN,
* Any ≥ grade 3 non-irAE, with some exclusions. Result is provided as number of participants with unacceptable toxicity within 8 weeks of commencing study therapy.

Disease Progression defined as the duration from date of registration to date of first documentation of progression as defined using Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 and assessed by local investigator or symptomatic deterioration (as defined in Outcome 1) or death due to any cause. Patients last known to be alive without report of progression are censored at date of last disease assessment. For patients with a missing scan (or consecutive missing scans) whose subsequent scan determines progression, the expected date of the first missing scan (as defined by the disease assessment schedule) will be used as the date of progression.

DMFS is defined as the duration from date of registration to date of first documentation of distant metastatic progression beyond the primary tumor site as well as regional lymph nodes assessed by local investigator or symptomatic deterioration (as defined in Outcome 1) or death due to any cause. Patients last known to be alive without report of distant metastatic progression are censored at date of last disease assessment.

ORR is defined as the proportion of all treated subjects whose best overall response is either a complete response or partial response according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. Best Objective Response (BOR) will also be reported Complete Response (CR) or Partial Response (PR) determinations included in the assessment must be confirmed by a consecutive second (confirmatory) evaluation meeting the criteria for response that is performed at least 4 weeks after the criteria for response are first met. When Stable Disease (SD) is believed to be the best response, it must meet a minimum SD duration of 49 days. Measurements must have met the SD criteria at least once after study entry.

H. Lee Moffitt Cancer Center and Research Institute

Thoracic Radiotherapy with cytotoxic platinum based chemotherapy with cytotoxic platinum based chemotherapy including cisplatin and etoposide, carboplatin and paclitaxel or cisplatin and pemetrexed (for patients with non-squamous histology) and Ipilimumab.

Thoracic Radiotherapy: 2 Gy in 30 fractions directed at all sites of suspected disease

Platinum Based Chemotherapy: Platinum based chemotherapy including cisplatin and etoposide, carboplatin and paclitaxel or cisplatin and pemetrexed (for patients with non-squamous histology).

Ipilimumab: Ipilimumab1mg/kg delivered concurrently with initiation of chemoradiotherapy and in week 4 of chemoradiotherapy

Nivolumab 480 mg (30 minute IV infusion) after completion of radiation and chemotherapy for up to 12 cycles until progression.

Nivolumab: Nivolumab 480 mg (30 minute IV infusion) at least 7 days but no more than 21 days after completion of radiation and chemotherapy every 4 weeks for up to 12 cycles.

Radiation and Chemotherapy, Followed by Nivolumab

Thoracic Radiotherapy with cytotoxic platinum based chemotherapy with cytotoxic platinum based chemotherapy including cisplatin and etoposide, carboplatin and paclitaxel or cisplatin and pemetrexed (for patients with non-squamous histology) and Ipilimumab.

Thoracic Radiotherapy: 2 Gy in 30 fractions directed at all sites of suspected disease

Platinum Based Chemotherapy: Platinum based chemotherapy including cisplatin and etoposide, carboplatin and paclitaxel or cisplatin and pemetrexed (for patients with non-squamous histology).

Ipilimumab: ipilimumab 1mg/kg delivered concurrently with initiation of chemoradiotherapy and in week 4 of chemoradiotherapy

Nivolumab 480 mg (30 minute IV infusion) after completion of radiation and chemotherapy for up to 12 cycles until progression.

Nivolumab: Nivolumab 480 mg (30 minute IV infusion) at least 7 days but no more than 21 days after completion of radiation and chemotherapy every 4 weeks for up to 12 cycles.

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Bradford A. Perez, MD

Thoracic Radiotherapy with cytotoxic platinum based chemotherapy with cytotoxic platinum based chemotherapy including cisplatin and etoposide, carboplatin and paclitaxel or cisplatin and pemetrexed (for patients with non-squamous histology) and Ipilimumab.

Thoracic Radiotherapy: 2 Gy in 30 fractions directed at all sites of suspected disease

Platinum Based Chemotherapy: Platinum based chemotherapy including cisplatin and etoposide, carboplatin and paclitaxel or cisplatin and pemetrexed (for patients with non-squamous histology).

Ipilimumab: Ipilimumab 1mg/kg delivered concurrently with initiation of chemoradiotherapy and in week 4 of chemoradiotherapy

Nivolumab 480 mg (30 minute IV infusion) after completion of radiation and chemotherapy for up to 12 cycles until progression.

Nivolumab: Nivolumab 480 mg (30 minute IV infusion) at least 7 days but no more than 21 days after completion of radiation and chemotherapy every 4 weeks for up to 12 cycles.

Unacceptable Toxicity Status at the End of 8-week Safety Observation Period

Percentage of Participants Without Disease Progression at 12 Months

Percentage of Participants Who Experienced 12 Month Distant Metastasis Free Survival (DMFS)

Objective Response Rate (ORR) at 6 Months

Thoracic Radiotherapy with cytotoxic platinum based chemotherapy with cytotoxic platinum based chemotherapy including cisplatin and etoposide, carboplatin and paclitaxel or cisplatin and pemetrexed (for patients with non-squamous histology) and ipilimumab .

Thoracic Radiotherapy: 2 Gy in 30 fractions directed at all sites of suspected disease

Platinum Based Chemotherapy: Platinum based chemotherapy including cisplatin and etoposide, carboplatin and paclitaxel or cisplatin and pemetrexed (for patients with non-squamous histology).

Ipilimumab: Ipilimumab 1mg/kg delivered concurrently with initiation of chemoradiotherapy and in week 4 of chemoradiotherapy

Nivolumab 480 mg (30 minute IV infusion) after completion of radiation and chemotherapy for up to 12 cycles until progression.

Nivolumab: Nivolumab 480 mg (30 minute IV infusion) at least 7 days but no more than 21 days after completion of radiation and chemotherapy every 4 weeks for up to 12 cycles.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase II Trial to Evaluate the Efficiency and Safety of Serplulimab Plus Chemotherapy as Conversion Therapy in NSCLC	NCT05837052	Unresectable Lu...	serplulimab plu...	18 Years - 75 Years	Zhejiang University
Durvalumab and Chemotherapy Induction Followed by Durvalumab and Radiotherapy in Large Volume Stage III NSCLC	NCT04765709	Non-small Cell ...	durvalumab plus... Durvalumab plus... durvalumab	18 Years -	Mario Negri Institute for Pharmacological Research
A Trial of GFH018 and Toripalimab in Combination With Concurrent Chemoradiotherapy in Stage III NSCLC Chemoradiotherapy in Stage III NSCLC	NCT05386888	NSCLC, Stage II...	GFH018 Toripalimab Paclitaxel Carboplatin Cisplatin Pemetrexed Thoracic Radiat... GFH018	18 Years -	Genfleet Therapeutics (Shanghai) Inc.
Datopotamab (DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer	NCT04940325	Metastatic Lung...	DS-1062a	18 Years -	Gustave Roussy, Cancer Campus, Grand Paris
Radiation Therapy (XRT) and ZD6474 in Non-Small Cell Lung Cancer (NSCLC)	NCT00745732	Non-Small Cell ...	ZD6474 (ZACTIMA... Radiation Thera...	18 Years -	M.D. Anderson Cancer Center
Radiation and Chemotherapy With Ipilimumab Followed by Nivolumab for Patients With Stage III Unresectable Non-Small Cell Lung Cancer (NSCLC)	NCT03663166	Carcinoma, Non-...	Thoracic Radiot... Platinum Based ... ipilimumab Nivolumab	18 Years -	H. Lee Moffitt Cancer Center and Research Institute

Spots Global Cancer Trial Database for unresectable nsclc