Symptoms and General Pathology

All Conditions

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

Recurrence

Carcinoma, Non-Small-Cell Lung

Carcinoma

Carcinoma, Bronchogenic

Bronchial Neoplasms

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Antineoplastic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Atezolizumab

Pirfenidone

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

Anti-Inflammatory Agents, Non-Steroidal

Analgesics, Non-Narcotic

Atezolizumab (Tecentriq) intravenous (IV) 1200mg flat dose day 1 then every 3 weeks.

Pirfenidone (Esbriet) orally (PO) with food according to this schedule:

Days 1-14: 267 milligrams (mg) orally three times per day (PO TID) Days 15-29: 534 mg PO TID Days 30 onward until progression: 801 mg PO TID

Atezolizumab is given as an intravenous infusion at 1200 mg every 3 weeks. Pirfenidone is taken by mouth 3 times a day with the dose increasing every 2 week until day 30

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Chao Huang, MD

The purpose of this study is to see if adding pirfenidone to atezolizumab will increase anti tumor activity and reduce treatment resistance in stage 4 and recurrent non- small cell lung cancer participants.

Combination of Atezolizumab and Pirfenidone in Second-line and Beyond NSCLC

CAFs (Combination of Atezolizumab and Pirfenidone in Second-line and Beyond NSCLC): a Phase I/II Study

parkview cancer institute

University of Kansas Medical Center

Micronutrients

Hematinics

Vitamins

Carboplatin

Bevacizumab

Pemetrexed

Immunomodulating Agents

Angiogenesis Inhibitors

Growth Inhibitors

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

Carboplatin (AUC 5) i.v. day 1 plus pemetrexed (500 mg/m2) i.v. day 1 plus atezolizumab 1200 mg i.v. day 1 plus bevacizumab 15 mg/kg i.v. day 1 every 3 weeks for up to 4 cycles.

Patients with non-PD after 4 cycles will be permitted to continue with maintenance therapy with pemetrexed plus atezolizumab plus bevacizumab every 3 weeks until the time of disease progression or intolerable toxicities.

Nasser Hanna, MD

This is a multicenter single arm phase II clinical trial. All eligible patients will receive:

Carboplatin (AUC 5) i.v. day 1 plus pemetrexed (500 mg/m2) i.v. day 1 plus atezolizumab 1200 mg i.v. day 1 plus bevacizumab 15 mg/kg i.v. day 1 every 3 weeks for up to 4 cycles.

Patients with non-PD after 4 cycles will be permitted to continue with maintenance therapy with pemetrexed plus atezolizumab plus bevacizumab every 3 weeks until the time of disease progression or intolerable toxicities.

The hypothesis of this study is that the addition of Atezolizumab (an anti-PD-L1 antibody), to the combination of Carboplatin plus Pemetrexed plus Bevacizumab, a vascular endothelial growth factor (VEGF) inhibitor, for the treatment of patients with stage IV non-squamous, non-small cell lung cancer (NSCLC) will improve progression free survival (PFS) compared with a historical control of carboplatin plus pemetrexed plus bevacizumab.

Single Arm Therapeutic study using historical controls

Carboplatin Plus Pemetrexed Plus Atezolizumab Plus Bevacizumab in Chemotherapy and Immunotherapy-naïve Patients With Stage IV Non-squamous Non-small Cell Lung Cancer

A Phase II Study of Carboplatin Plus Pemetrexed Plus Atezolizumab Plus Bevacizumab in Chemotherapy and Immunotherapy-naïve Patients With Stage IV Non-squamous Non-small Cell Lung Cancer: Big Ten Cancer Research Consortium BTCRC-LUN17-139

Progression free survival (PFS) defined as the time from the initiation of treatment to the time when the criteria for disease progression is met as defined by RECIST v1.1 or death of any cause.Disease progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

Overall Response rate will include confirmed complete response (CR) + confirmed partial response (PR), as determined as per RECIST v1.1 criteria and assessed by the local investigator or designee.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Disease control rate will include complete response (CR\], partial response (PR), and stable disease (SD), as per RECIST v1.1 criteria.

To estimate the overall survival (OS) of carboplatin plus pemetrexed plus atezolizumab plus bevacizumab in immunotherapy and chemotherapy-naïve patients with stage IV non-squamous non-small cell lung cancer.

To characterize the toxicity of carboplatin plus pemetrexed plus atezolizumab plus bevacizumab in immunotherapy and chemotherapy-naïve patients with stage IV non-squamous non-small cell lung cancer as defined by the NCI Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.

Genentech, Inc.

Nasser Hanna

Sponsor-Investigator

An Adverse Event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Carboplatin (AUC 5) i.v. day 1 plus pemetrexed (500 mg/m2) i.v. day 1 plus atezolizumab 1200 mg i.v. day 1 plus bevacizumab 15 mg/kg i.v. day 1 every 3 weeks for up to 4 cycles.

Patients with non-PD after 4 cycles will be permitted to continue with maintenance therapy with pemetrexed plus atezolizumab plus bevacizumab every 3 weeks until the time of disease progression or intolerable toxicities.

Carboplatin: Carboplatin, AUC 5

Pemetrexed: Pemetrexed 500mg/m2

Atezolizumab: Atezolizumab 1200mg

Bevacizumab: Bevacizumab 15mg/kg

Arm A: Carboplatin + Pemetrexed + Atezolizumab + Bevacizumab

Age, Continuous

Gender

Sex/Gender, Customized

Ethnicity (NIH/OMB)

RACE

Race/Ethnicity, Customized

Stage IV: This stage means that the cancer has spread to other organs or parts of the body. It may be also called advanced or metastatic cancer.

Recurrent Disease: Recurrent Disease is cancer that returns after a period of complete remission. The same type of cancer cells originally found and treated come back in the same or a different location in the body after at least one year of having no detectable evidence of disease.

Disease Status at Study Entry

The PD-L1 expression was determined by the Tumor Proportion Score (TPS), the percentage of viable tumor cells showing partial or complete membrane staining at any intensity and classified into TPS \<1%: No PD-L1 expression TPS 1 to 49%: Low PD-L1 expression TPS ≥50% : High PD-L1 expression

PD-L1 Expression Category(Dako 22C3)

NSCLSC : non- small cell lung cancer NOS : not otherwise specified

Primary Histology

Smoking Status

Received chemotherapy previously

ECOG Performance Status can be described as :

0 Fully active; no performance restrictions.

1. Strenuous physical activity restricted; fully ambulatory and able to carry out light work.
2. Capable of all self-care but unable to carry out any work activities. Up and about \>50% of waking hours.
3. Capable of only limited self-care; confined to bed or chair \>50% of waking hours.
4. Completely disabled; cannot carry out any self-care; totally confined to bed or chair.

Baseline ECOG

EGFR Mutation testing done

ALK Mutation testing done

ROS-1 Rearrangement testing done

HER-2 Mutation testing done

RET Translocation testing done

MET Mutation testing done

KRAS Mutation testing done

NTRK Fusion testing done

BRAF Mutation testing done

Tumor Mutational Burden

Annesha Majumdar

Arm A

Progression Free Survival

Two patients died prior to first post-baseline assessments.Therefore, 28 out of 30 subjects are analyzed for this objective.

Overall Response Rate

Disease Control Rate

Overall Survival

Patient had at least one adverse event of any grade

Patient had at least one grade 3 or greater adverse event

Patient had at least one grade 3 or greater treatment related adverse event

Patient had serious adverse event

Number of Participants With Adverse Events

Study Treatment

Follow up

Zhengfei Zhu, MD

Xiao Chu, PhD

Xiao Chu

By prospectively observing the time to the best therapeutic effect of non-small cell lung cancer after ICI treatment, the characteristics of lesion distribution when the best therapeutic effect is reached, and the phenotype of disease progression after ICI treatment response, the investigators intended to explore the failure pattern of NSCLC after the once effective ICI treatment. The investigators also aim to evaluate the feasibility and clinical value of radiotherapy for the treatment of oligo-progressive lesions after ICI.

Prospective Observation of Failure Patterns in NSCLC Treated With ICIs

Prospective Observational Study of Failure Patterns in Non-small Cell Lung Cancer Patients Treated With Immune Checkpoint Inhibitors

Acquired resistance (AR) was defined as disease progression after partial or complete response (PR or CR) to ICI treatment. (by RECIST standard v1.1)

When observing disease progression in ICI treatment, the number and distribution of progression lesions were recorded.

Oligo-progression disease (OPD) was defined as 1-3 progression lesions in 1-2 organs. The OPD rate in all AR cases will be calculated.

When radiotherapy to at least one of the OPD lesions is indicated in the opinion of the investigator. Overall objective response rate (ORR) to radiotherapy will be recorded. ORR was defined as the proportion of participants with partial response (PR) or complete response (CR) to treatment as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.

Objective response rate (ORR) in Non-irradiated Lesion was defined as the proportion of patients with at least 30% reduction from baseline in the longest diameter of any of non-irradiated target lesions defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at any time-point from the date of treatment initiation to the date of last follow-up.

Treatment-related adverse events were assessed and graded according to CTCAE v. 5.0.

OS was defined as the time from the date of enrollment until death by any cause. Participants still alive at the time of data analysis were censored at the date of last follow-up.

Fudan University

Professor

Microbiome in immunotherapy naïve NSCLC patients receiving PD-1/L1 blockade

Nasal and buccal swabs, and stool sample, as well as the extracted DNAs

Microbiome

Jun Zhang, MD, PhD

This phase IV study is hoping to determine if examining the microbiome in non-small cell lung cancer, immunotherapy naive participants can predict the effectiveness of immunotherapy treatment as well as determine ahead of time adverse events and their severity. In addition, the investigator will look into microbiome changing modifiers.

Nasal and buccal swabs, and stool sample, as well as the extracted DNAs for current and future, study-related research

Microbiome in Immunotherapy naïve NSCLC Patients Receiving PD-1/L1 Blockade (MIP_NSCLC)

Adverse events (AEs) will be graded per the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Treatment response will be evaluated using the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1

PD-L1 expression is per standard of care using IHC

Associate Professor; Principal Investigator

Rare Diseases

Adenocarcinoma

Adenocarcinoma of Lung

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Lung Adenocarcinoma

Paclitaxel

Albumin-Bound Paclitaxel

Nintedanib

Tubulin Modulators

Antimitotic Agents

Protein Kinase Inhibitors

A dose-finding study of nintedanib (Vargatef) with nab-paclitaxel (Abraxane) with a standard 3+3 design. In the dose escalation part there will be 3 dose cohorts of nintedanib:

Dose level -1: 100mg po BID d2-7, 9-21, q21 Dose level 1: 150mg po BID d2-7, 9-21, q21 Dose level 2: 200mg po BID d2-7, 9-21, q21

In the dose expansion part, 6 additional patients will be enrolled at the maximum tolerated dose (MTD) of nintedanib (Vargatef) with nab-paclitaxel (Abraxane), prior to proceeding to part 2.

A placebo-controlled, randomised, double-blind, 2-arm, phase 2 multi-centre clinical trial of nab-paclitaxel (Abraxane) with nintedanib (Vargatef) and nab-paclitaxel alone.

Arm A: nab-paclitaxel + placebo Arm B: nab-paclitaxel + nintedanib

Vargatef

Paclitaxel formulated as albumin bound nanoparticles

Abraxane

placebo

Sanjay Popat

A PHASE I/II TRIAL OF COMBINATION NAB-PACLITAXEL AND NINTEDANIB OR NAB-PACLITAXEL AND PLACEBO IN RELAPSED NSCLC ADENOCARCINOMA

The study is divided into 2 parts: Part 1 is the Phase Ib portion of the trial and Part 2 is the Phase II portion of the trial. Once the Trial Steering Committee has completed the dose limiting toxicity (DLT) assessment for Part 1 and confirmed RP2D for Part 2, Part 2 enrolment will proceed. The objective(s) for each part are as follows:

Part 1: The objective of Part 1 is to evaluate the safety and tolerability of combination nab-paclitaxel and nintedanib in patients with stage IIIb and IV adenocarcinoma of the lung in second and third treatment line setting and to determine the maximum tolerated dose (MTD)/recommended phase 2 dose (RP2D) of nintedanib when given with nab-paclitaxel at 100mg/m2 d1, d8 q21.

Part 2: The primary objective of Part 2 is to explore the efficacy of combination nab-paclitaxel and nintedanib versus nab-paclitaxel and placebo in the same patient population, with nintedanib/placebo given at the recommended phase 2 dose (RP2D) as defined during part 1 of the study.

Part I: A dose-escalation - standard 3+3 design. Part 2: A placebo-controlled, randomised, double-blind, 2-arms.

Part 2 only of the study is double-blinded. 2 arms

Combination Nab-paclitaxel (N-P) and Nintedanib or N-P and Placebo in Relapsed NSCLC Adenocarcinoma

A Phase I Trial of Combination Nab-Paclitaxel and Nintedanib or Nab-paclitaxel and Placebo in Relapsed Non-Small Cell Lung Cancer Adenocarcinoma

To explore PFS rate at 12 weeks from first dose of nab-paclitaxel with nintedanib/placebo

To define Maximum tolerated dose (MTD) and evaluate incidence of dose-limiting toxicities (DLTs) during Cycle 1

To examine the frequency of all Adverse Events graded by NCI-CTCAE version 4.0

To examine the objective tumour response according to RECIST 1.1

To define the number of cycles of nab-paclitaxel with nintedanib given

To examine overall survival in the ITT and predefined subgroups (PD pre/post 9 months from start of first line chemotherapy; prior or no prior immunotherapy).

Boehringer Ingelheim

Celgene

Royal Marsden NHS Foundation Trust

Amino Acids

Dacomitinib

Tyrosine Kinase Inhibitors

Tyrosine

Sequential Therapy with Dacomitinib as First-line Treatment Followed by 3rd generation EGFR-TKI in Patients with EGFR Mutation Positive Advanced Non-Small Cell Lung Cancer

effectiveness and safety profile in patients with EGFR mutation-positive advanced NSCLC treated with dacomitinib (Vizimpro®) as the first-line treatment followed by 3rd generation EGFR-TKI in case the T790M resistance mutation was developed.

Puyuan Xing, PhD

Dawei Wu, PhD

Junling Li, MD

This is a non-interventional, multi-center, ambispective cohort study in real world to describe the effectiveness and safety profile in patients with EGFR mutation-positive advanced NSCLC treated with dacomitinib (Vizimpro®) as the first-line treatment followed by 3rd generation EGFR-TKI in case the T790M resistance mutation was developed.

This is a multi-center observational study with both retrospective and prospective data collections to describe the effectiveness and safety of sequential dacomitinib and 3rd generation EGFR-TKI used in patients with EGFR mutation-positive NSCLC with T790M-aquired resistance in a clinical practice setting. The study will include patients who were or will be diagnosed as advanced NSCLC with EGFR mutation positive and received dacomitinib as first-line treatment followed by second-line 3rd generation EGFR-TKI treatment in multiple tertiary care hospitals after Sep 1st, 2019. Patients' clinical information prior to the study initiation in each hospital will be collected retrospectively through chart review. After the study initiation, new patient enrollment will last till Dec 2022. Patients' clinical care after the study initiation will be followed up prospectively until the end of study. The interval of response evaluation is recommended to be every 2 to 3 months in the treatment period and the interval of follow-up is recommended to be every 2 to 3 months in the post-treatment period till the end of study in the prospective data collection period.

blood sample will be taken when each patient were reexamined in hospital

Dacomitinib Treatment Followed by 3rd Generation EGFR-TKI in Patients With EGFR Mutation Positive Advanced NSCLC

Real-world Study on Sequential Therapy With Dacomitinib as First-line Treatment Followed by 3rd Generation EGFR-TKI in Patients With EGFR Mutation Positive Advanced Non-Small Cell Lung Cancer

To describe the time to treatment failure (TTF) of sequential dacomitinib and 3rd generation EGFR-TKI used in patients with EGFR mutation-positive NSCLC and T790M-aquired resistance in China.

To describe the progression-free survival (PFS) of dacomitinib and 3rd generation EGFR-TKI used in patients with EGFR mutation-positive NSCLC with T790M-aquired resistance in China.

To describe the duration of treatment (DOT) of dacomitinib and 3rd generation EGFR-TKI used in patients with EGFR mutation-positive NSCLC with T790M-aquired resistance respectively in China.

To describe the overall survival (OS) of sequential dacomitinib and 3rd generation EGFR-TKI used in patients with EGFR mutation-positive NSCLC and T790M-aquired resistance in China.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Combination of Atezolizumab and Pirfenidone in Second-line and Beyond NSCLC	NCT04467723	NSCLC Stage IV NSCLC, Recurren...	Atezolizumab	18 Years -	University of Kansas Medical Center
Carboplatin Plus Pemetrexed Plus Atezolizumab Plus Bevacizumab in Chemotherapy and Immunotherapy-naïve Patients With Stage IV Non-squamous Non-small Cell Lung Cancer	NCT03713944	NSCLC Stage IV NSCLC, Recurren...	Carboplatin Pemetrexed Atezolizumab Bevacizumab	18 Years -	Big Ten Cancer Research Consortium
Prospective Observation of Failure Patterns in NSCLC Treated With ICIs	NCT04492969	NSCLC Stage IV NSCLC, Recurren...		18 Years - 75 Years	Fudan University
Microbiome in Immunotherapy naïve NSCLC Patients Receiving PD-1/L1 Blockade (MIP_NSCLC)	NCT04636775	NSCLC Stage IV NSCLC, Recurren...	Microbiome	18 Years -	University of Kansas Medical Center
Carboplatin Plus Pemetrexed Plus Atezolizumab Plus Bevacizumab in Chemotherapy and Immunotherapy-naïve Patients With Stage IV Non-squamous Non-small Cell Lung Cancer	NCT03713944	NSCLC Stage IV NSCLC, Recurren...	Carboplatin Pemetrexed Atezolizumab Bevacizumab	18 Years -	Big Ten Cancer Research Consortium
Prospective Observation of Failure Patterns in NSCLC Treated With ICIs	NCT04492969	NSCLC Stage IV NSCLC, Recurren...		18 Years - 75 Years	Fudan University
Combination Nab-paclitaxel (N-P) and Nintedanib or N-P and Placebo in Relapsed NSCLC Adenocarcinoma	NCT03361319	NSCLC, Recurren... Adenocarcinoma ...	Vargatef Abraxane placebo	18 Years -	Royal Marsden NHS Foundation Trust
Dacomitinib Treatment Followed by 3rd Generation EGFR-TKI in Patients With EGFR Mutation Positive Advanced NSCLC	NCT04768491	EGFR Activating... NSCLC Stage IV NSCLC Stage III... NSCLC, Recurren...	Dacomitinib	18 Years -	Peking Union Medical College
Combination Nab-paclitaxel (N-P) and Nintedanib or N-P and Placebo in Relapsed NSCLC Adenocarcinoma	NCT03361319	NSCLC, Recurren... Adenocarcinoma ...	Vargatef Abraxane placebo	18 Years -	Royal Marsden NHS Foundation Trust

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