Combining chemotherapy with immune therapy for specific lung cancer mutations

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to evaluate the efficacy and safety of platinum-based chemotherapy combined with immune checkpoint inhibitors in patients with EGFR, ALK, or ROS1 mutant non-small cell lung cancer (NSCLC) who have failed first-line treatments. The study is divided into three cohorts based on the specific mutations: EGFR, ALK, and ROS1. Participants will undergo treatment with drugs such as Pemetrexed, Cisplatin, Bevacizumab, and Pembrolizumab, and their safety and efficacy will be closely monitored. Additionally, tissue and blood samples will be collected for advanced analysis of the tumor microenvironment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

Cancer-Specific Exclusions:

* 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.

General Medical Exclusions:

* 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.

Exclusion Criteria Related to Medications:

• Prior treatment with cluster of differentiation 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1, and anti-PD-L1 therapeutic antibodies.

Where it's running

• Hunan Cancer Hospital
  Changsha, Hunan, China Recruiting

Study contacts

• Principal investigator: Yongchang Zhang, MD — Hunan Cancer Hospital
• Study coordinator: Yongchang Zhang, MD
• Email: zhangyongchang@csu.edu.cn
• Phone: +8613873123436

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.