Efficacy of Platinum-based Chemotherapy Plus Immune Checkpoint Inhibitors for EGFR/ALK/ROS1 Mutant Lung Cancer

NCT05284539 | Recruiting Phase 2

• 1 other identifier: 20220117
• Study Type: interventional
• Target: 760
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators want to evaluate the Efficay and Safety of Platinum-based Chemotherapy with or without immune checkpoint inhibitors for EGFR/ALK/ROS1 Positive NSCLC who Failed from First-Line Standard Treatment.

Conditions

Non Small Cell Lung Cancer

Keywords

EGFR; ALK; ROS1; PD-1 Blockade

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  To assess progression-free survival of patients treated with Immune Checkpoint Inhibitor, Bevacizumab in combination with Chemotherapy according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 by investigator, define as first dose to first documented disease progression assessed by investigator or death due to any cause

  Time from first subject dose to study completion, or up to 36 month

Secondary Outcomes (3)

• Objective Response Rate (ORR)

  Time from first dose to last dose, or up to 24 month

• Overall survival (OS)

  Time from first subject dose to study completion, or up to 36 month

• Adverse events (AEs) according to CTCAE 5.0

  From first dose until 28 days after the last dose, up to 24 month

Study Arms (3)

Arm A: EGFR mutant Group

EXPERIMENTAL

EGFR mutant Group.

Drug: Pemetrexed, Cisplatin, Bevacizumab Plus Pembrolizumab

Arm B: ALK fusion Group

EXPERIMENTAL

ALK fusion Group.

Drug: Pemetrexed, Cisplatin, Bevacizumab Plus Pembrolizumab

Cohort C: ROS1 fusion Group.

EXPERIMENTAL

ROS1 fusion Group.

Drug: Pemetrexed, Cisplatin, Bevacizumab Plus Pembrolizumab

Interventions

Pemetrexed, Cisplatin, Bevacizumab Plus Pembrolizumab DRUG

Pemetrexed, 500mg/m2, ivgtt, every 21 days. Bevacizumab 15mg/kg, ivgtt, every 21 days. Pembrolizumab, 200mg ivgtt, every 21 days. Atezolizumab, 1200mg, ivgtt, every 21 days.

Also known as: Pemetrexed, Bevacizumab, Pembrolizumab, Atezolizumab

Arm A: EGFR mutant Group; Arm B: ALK fusion Group; Cohort C: ROS1 fusion Group.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form.
• Age ≥ 18 years.
• Histologically or cytologically confirmed, Stage IV NSCLC.
• EGFR/ALK/ROS1-sensitive mutations confirmed by an accredited local laboratory, progressed from first line systematic therapy.
• ECOG 0-1.
• Predicted survival ≥ 12 weeks.
• Adequate bone marrow hematopoiesis and organ function
• Presence of measurable lesions according to RECIST 1.1.

You may not qualify if:

• Active or untreated central nervous system metastases.
• Malignancies other than NSCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome.
• Pregnant or lactating women.
• History of autoimmune disease.
• History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
• Positive test for human immunodeficiency virus.
• Active hepatitis B or hepatitis C.
• Severe infection within 4 weeks prior to randomization.
• Significant cardiovascular disease.
• Illness or condition that interferes with the participant's capacity to understand, follow and/or comply with study procedures.
• Prior treatment with cluster of differentiation 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1, and anti-PD-L1 therapeutic antibodies.

Sponsors & Collaborators

• Hunan Province Tumor Hospital: lead

Study Sites (1)

Hunan Cancer Hospital

Changsha, Hunan, 410013, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Pemetrexed; Cisplatin; Bevacizumab; pembrolizumab; atezolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Officials

• Yongchang Zhang, MD

  Hunan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongchang Zhang, MD

CONTACT

+8613873123436; zhangyongchang@csu.edu.cn

Nong Yang, MD

CONTACT

+8613873123436; yangnong0217@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Medical Oncology, Director of Early Clinical Trial Center

Study Record Dates

• First Submitted: January 22, 2022
• First Posted: March 17, 2022
• Study Start: April 1, 2022
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): October 10, 2027
• Last Updated: June 7, 2024

Record last verified: 2024-06

Locations

CN (1)