Combining Pembrolizumab, Bevacizumab, and Chemotherapy for Advanced Lung Cancer with ALK Mutation

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 phase II clinical trial evaluates the safety and efficacy of Pembrolizumab and Bevacizumab in combination with chemotherapy for patients with advanced lung adenocarcinoma that has an ALK gene mutation and has not responded to Alectinib. The study involves administering Pembrolizumab and Bevacizumab along with chemotherapy agents Pemetrexed and Carboplatin over multiple cycles. Patients will be monitored for progression-free survival and overall response to the treatment. The trial aims to gather data on the effectiveness of this combination therapy in a specific patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years of age on day of signing informed consent.

  * Stage IV ALK-rearranged Lung Adenocarcinoma Persistent with 5'ALK Failed from first line Alectinib

    * Have at least 1 lesion that meets the criteria for being measurable, as defined by RECIST 1.1, and is appropriate for selection as a target lesion, as determined by local site investigator radiology review. Lesions that appear measurable, but have undergone palliative irradiation, cannot be target lesions ④20 FFPE sliders prepared,Subjects who do not have histology samples (defined as core or excisional biopsy, or resections) will need to undergo a new biopsy to provide a tissue sample ⑤Eastern Cooperative Oncology Group performance status 0 or 1

      * Life expectancy ≥3 months

        * Adequate hematologic and end organ function

Exclusion Criteria:

Cancer-Specific Exclusions:

①Active or untreated central nervous system metastases

②Malignancies 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.

  * Has active autoimmune disease that has required systemic treatment in the past 2 years.

    * 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.

        ⑤Active hepatitis B or hepatitis C.

        ⑥Severe infection within 4 weeks prior to randomization .

        ⑦Significant cardiovascular disease.

        ⑧Illness or condition that interferes with the participant's capacity to understand, follow and/or comply with study procedures.

        ⑨Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment for another health-related problem.

Exclusion Criteria Related to Medications: Prior treatment with anti-programmed death-1, anti-PD-L1 therapeutic antibodies，and anti-VEGF agents.

Where it's running

• Hunan Cancer Hospital
  Changsha, Hunan, China Recruiting

Study contacts

• Principal investigator: Yongchang C Zhang, MD — Hunan Cancer Hospital
• Study coordinator: Yongchang C 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.