Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Rare Diseases

Lung Neoplasms

Small Cell Lung Carcinoma

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

Antineoplastic Agents

All Drugs and Chemicals

Etoposide

Carboplatin

Cisplatin

Immunomodulating Agents

Durvalumab

Etoposide phosphate

Enzyme Inhibitors

Antineoplastic Agents, Immunological

On Day 1 of every Cycle for the first 4 Cycles (Cycle = 21 Days):

Durvalumab 1500mg IV, Monalizumab 1500mg IV, Either Carboplatin AUC 5-6 OR Cisplatin 75-80mg/m\^2

On Days 1-3 of every Cycle for the first 4 Cycles:

Etoposide 80-100mg/m\^2

On Day 1 of Cycles 5+ (Cycle = 28 Days):

Durvalumab 1500mg IV Monalizumab 1500mg IV

Monalizumab

On Day 1 of Cycles 1-4 by IV:

Carboplatin: AUC 5-6 OR Cisplatin: 75-80mg/m\^2

Carboplatin or Cisplatin

80-100mg/m\^2 IV on Days 1-3 of Cycles 1-4

Hirva Mamdani, MD

Milena Petkov

Lacey Garrett

Ryan Gentzler, MD

The study treatment will consist of a platinum drug (carboplatin or cisplatin per investigator's choice) plus etoposide plus durvalumab plus monalizumab every 3 weeks for 4 cycles. After 4 cycles, subjects will continue maintenance treatment with durvalumab plus monalizumab every 4 weeks until disease progression, unacceptable toxicity, decision to stop study treatment, or withdrawal of consent. Patients who have received one prior cycle of treatment before enrolling on the study will receive a total of 4 cycles with monalizumab, durvalumab, and chemotherapy. There will be a safety lead-in phase, including 6 to 12 patients, to confirm the safety of the proposed dose of monalizumab to use in combination with chemotherapy and durvalumab.

MOnaliZumab in Combination With durvAlumab (MEDI4736) Plus Platinum-based chemotheRapy for First-line Treatment of Extensive Stage Small Cell Lung Cancer

A Phase II Trial of MOnaliZumab in Combination With durvAlumab (MEDI4736) Plus Platinum-based chemotheRapy for First-line Treatment of Extensive Stage Small Cell Lung Cancer (MOZART)

PFS is defined as the time from Day 1 of treatment (i.e., Day 1 of the first cycle of systemic therapy for SCLC, on study or initiated prior to enrolling on the study, whichever occurs first) until the criteria for disease progression is met as defined by RECIST 1.1 or death as a result of any cause.

Safety and tolerability will be assessed by the grading of adverse events based on Common Toxicity Criteria for Adverse Events (CTCAE) v5.

The objective response rate is the proportion of all subjects with confirmed PR or CR according to RECIST 1.1, from the start of treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the start of treatment)

OS is defined as the time from Day 1 of treatment (i.e., Day 1 of the first cycle of systemic therapy for SCLC, on study or initiated prior to enrolling on the study, whichever occurs first) until death as a result of any cause.

iPFS is defined as the time from Day 1 of treatment (i.e., Day 1 of the first cycle of systemic therapy for SCLC, on study or initiated prior to enrolling on the study, whichever occurs first) until the criteria for intracranial disease progression is met as defined by RECIST 1.1 or administration of brain radiation or death as a result of any cause, whichever comes first.

AstraZeneca

Barbara Ann Karmanos Cancer Institute

Hirva Mamdani

Sponsor-Investigator

Digestive System Diseases

Carcinoma, Squamous Cell

Esophageal Squamous Cell Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Pembrolizumab

Docetaxel

Tubulin Modulators

Antimitotic Agents

Immune Checkpoint Inhibitors

Neoadjuvant Pembrolizumab Plus Chemotherapy

Carboplatin Area Under the Curve(AUC) = 4-5 i.v. day 1-22-43-64 or Cisplatin 75mg/m2 i.v. day 1-22-43-64

Li Li, MD

This is a study to evaluate the efficacy and safety of neoadjuvant pembrolizumab plus chemotherapy in resectable locally advanced esophageal squamous cell carcinoma patients

The primary objective of the study is to assess the tumor response (by irRECIST) and pathological response of neoadjuvant pembrolizumab plus chemotherapy (carboplatin, paclitaxel).

Secondary objectives are:

To assess completion of neoadjuvant pembrolizumab plus chemotherapy. To assess toxicities of neoadjuvant pembrolizumab plus chemotherapy To assess completion of neoadjuvant pembrolizumab plus chemotherapy. To assess withdrawal rate from surgery. To assess delay rate from surgery. To assess R0 resection rate. To assess post-operative complications. Progression Free Survival.

Neoadjuvant Pembrolizumab Plus Chemotherapy for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma

A Prospective, Single-armed Study to Evaluate the Efficacy and Safety of Neoadjuvant Pembrolizumab Plus Chemotherapy in Resectable Locally Advanced Esophageal Squamous Cell Carcinoma Patients

assess the tumor response (by irRECIST) of neoadjuvant pembrolizumab plus chemotherapy

assess the pathological responses (by College of American Pathologists(CAP) classification) of neoadjuvant pembrolizumab plus chemotherapy

Percentage completion of treatment in neoadjuvant pembrolizumab plus chemotherapy

Incidence and severity of toxicity defined to CTCAE v4.03 and Radiation Oncology Group (RTOG) criteria

Percentage withdrawal rate from surgery due to neoadjuvant related complications

Percentage delay of surgery due to neoadjuvant related complications

Incidence and severity of post-operative complications to the Clavien-Dindo classification

Peking Union Medical College Hospital

Carcinoma, Non-Small-Cell Lung

Micronutrients

Hematinics

Vitamins

Paclitaxel

Bevacizumab

Pemetrexed

Albumin-Bound Paclitaxel

Atezolizumab

Angiogenesis Inhibitors

Growth Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Folinic Acid

Folate

Vitamin B9

Atezolizumab(1200 mg IV);Over 60 (± 15) min (for the first infusion); 30 (± 10) min for subsequent infusions if tolerated Frequency: Day 1 of every 21 days Induction: Four or Six Cycles Maintenance : until PD

Atezolizumab(Tecentriq)

Induction Period (Four or Six Cycles)

(1) Pemetrexed(500 mg/m2 IV); Over approximately10 minutes on Day 1 q3w

Maintenance Period (Until PD) Pemetrexed(500 mg/m2 IV); Over approximately10 minutes on Day 1 q3w

Bevacizumab(15 mg/kg IV);Over 90 (±15) min (for the first infusion); shortening to 60 (± 10) then 30 (± 10) min for subsequent infusions if tolerated

Carboplatin(AUC 5 or 5.5 IV a); Over approximately 15-30 min

Carboplatin(AUC 5.5 IV);Over approximately 30-60 minutes on Day 1 q3W or Cisplatin(75 mg/m²) ; Over 1-2 hours on Day 1 q3w

Carboplatin or cisplatin

Myung-Ju Ahn, MD

This randomized, Phase III, multicenter, open-label study designed to evaluate the efficacy of Atezolizumab in combination with carboplatin, paclitaxel, bevacizumab compared with treatment with pemetrexed, cisplatin in approximately 228 TKI(tyrosine kinase inhibitor) pre treated patients with Stage IV non squamous non small cell lung cancer with activating EGFR mutation or ALK translocation.

Study of Atezolizumab Combination Carboplatin + Paclitaxel + Bevacizumab in EGRF Mutation or ALK Translocation NSCLC

Study of Atezolizumab in Combination With Carboplatin + Paclitaxel +Bevacizumab vs With Pemetrexed + Cisplatin or Carboplatin With Stage IV NON-SQUAMOUS NON-SMALL CELL LUNG CANCER With EGFR(+) or ALK(+)

CNS metastasis(brain, spinal cord, ophthalmic..)

To evaluate the efficacy of atezolizumab + carboplatin + paclitaxel + bevacizumab as progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 (RECIST v1.1) in the following treatment:Atezolizumab + carboplatin + paclitaxel + bevacizumab versus Pemetrexed + carboplatin or cisplatin

Samsung Medical Center

M.D. Professor Division of Hematology-Oncology Department of Medicine

Antibodies

Tislelizumab

Immunoglobulins

Participants receive 2-4 cycles of Tislelizumab combined with chemotherapy treatment during preoperative period, every 3 weeks for 4 cycles at most.

Tislelizumab: 200mg, ivgtt, day 1 of each 21-day cycle, neoadjuvant therapy : 2-4 cycles; Adjuvant therapy: 16cycles at most.

Pemetrexed: 500 mg/m\^2, ivgtt, day 1 of each 21-day cycle, 2-4 cycles. Nab-paclitaxel: 260mg/m\^2, ivgtt, day 1 of each 21-day cycle, 2-4 cycles.

Pemetrexed (Non-squamous NSCLC) or Nab-paclitaxel(Squamous NSCLC)

Carboplatin was given dosed to an area under the serum concentration-time curve (AUC) of 5 ivgtt on day 1 of each 21-day cycle for 2-4 cycles.

Cisplatin: 75 mg/m\^2, ivgtt, day 1 of each 21-day cycle, 2-4 cycles.

Surgery must be done within the 4th-6th week from day 1 the last cycle of neoadjuvant treatment.

Surgery

Zhe Wu, PhD

Wenjie Jiao, PhD

Explorative study, which evaluates the effect of Tislelizumab combined with chemotherapy in neoadjuvant treatment of stage Ⅲ unresectable non-small-cell lung carcinoma.

This is a open-label, single-arm prospective clinical trial to evaluate the efficacy and safety of Tislelizumab combined with chemotherapy in neoadjuvant treatment of newly diagnosed stage Ⅲ unresectable non-small cell lung cancer.

Preoperative Neoadjuvant Immunotherapy Combined With Chemotherapy for Stage Ⅲ Unresectable Non-small Cell Lung Cancer

Preoperative Neoadjuvant Immunotherapy Combined With Chemotherapy for Newly Diagnosed Stage Ⅲ Unresectable Non-small Cell Lung Cancer: a Open-label, Single-arm Prospective Clinical Trial

Pathological Complete Response (pCR) Rate: no residual tumor cells in the surgically resected tumor specimen and all sampled regional lymph nodes after neoadjuvant treatment.

R0 Resection Rate: The pathological results will showed that the incision margin was negative and no residual cancer cells were found under the microscope.

Objective Response Rate (ORR): defined as the proportion of patients whose tumor size shrinks to predefined values，which including cases of CR and PR. Objective tumor response will be assessed using RECIST 1.1. Subjects must have measurable tumor lesions at baseline, and the response evaluation criteria are classified as complete response (CR), partial response (PR), stable disease (SD), and progressive disease (PD) according to RECIST 1.1.

Resectability Rate is defined as the percentage of patients who were able to undergo surgery after neoadjuvant therapy.

Major Pathological Response (MPR) Rate: defined as ≤ 10% of residual tumor cells in the surgically resected tumor specimen and sampled regional lymph nodes after neoadjuvant treatment.

Adverse events will be evaluated and recorded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 5.0).

Progression-Free Survival (PFS): defined as the time from the first dose until the date of first documented progression or date of death from any cause, whichever came first.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
MOnaliZumab in Combination With durvAlumab (MEDI4736) Plus Platinum-based chemotheRapy for First-line Treatment of Extensive Stage Small Cell Lung Cancer	NCT05903092	Small Cell Lung... SCLC Extensive Stage...	Durvalumab Monalizumab Carboplatin or ... Etoposide	18 Years -	Hoosier Cancer Research Network
Neoadjuvant Pembrolizumab Plus Chemotherapy for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma	NCT05302011	Esophageal Squa...	Pembrolizumab Carboplatin or ... Docetaxel	18 Years -	Peking Union Medical College Hospital
Neoadjuvant Pembrolizumab Plus Chemotherapy for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma	NCT05302011	Esophageal Squa...	Pembrolizumab Carboplatin or ... Docetaxel	18 Years -	Peking Union Medical College Hospital
Study of Atezolizumab Combination Carboplatin + Paclitaxel + Bevacizumab in EGRF Mutation or ALK Translocation NSCLC	NCT03991403	Non-small Cell ...	Atezolizumab(Te... Pemetrexed Bevacizumab Carboplatin Paclitaxel Carboplatin or ...	18 Years -	Samsung Medical Center
Preoperative Neoadjuvant Immunotherapy Combined With Chemotherapy for Stage Ⅲ Unresectable Non-small Cell Lung Cancer	NCT06357598	Non-small-cell ...	Tislelizumab Pemetrexed (Non... Carboplatin or ... Surgery	18 Years - 75 Years	The Affiliated Hospital of Qingdao University
Study of Atezolizumab Combination Carboplatin + Paclitaxel + Bevacizumab in EGRF Mutation or ALK Translocation NSCLC	NCT03991403	Non-small Cell ...	Atezolizumab(Te... Pemetrexed Bevacizumab Carboplatin Paclitaxel Carboplatin or ...	18 Years -	Samsung Medical Center

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