A Phase II Study of Anlotinib and Platinum-Based Chemotherapy in Patients With SMARCA4-Deficient, Locally Advanced or Metastatic Lung Cancer.

• Status: NOT_YET_RECRUITING
• Trial end date: 2028-01-01

Summary

The goal of this clinical trial is to evaluate the efficacy and safety of combining Anlotinib with platinum-based chemotherapy for treating locally advanced or advanced lung cancer in patients whose tumors are characterized by SMARCA4 deficiency, as evidenced by the loss of BRG1 protein via immunohistochemistry (IHC). It will also learn about the safety of this combination treatment.

The main questions it aims to answer are:

1. How long can this treatment delay the worsening of the cancer (Progression-Free Survival, PFS)?

2. What side effects or medical problems do participants have when taking this combination? This is a single-arm study, meaning all participants will receive the same investigational combination therapy. Researchers will monitor how well the cancer responds and compare the results to historical data from similar patients who received other treatments.

Participants will:

1. Receive treatment in 21-day cycles: take Anlotinib pills on days 1-14 of each cycle and receive platinum-based chemotherapy by intravenous infusion on day 1 (or days 1 and 8).

2. Undergo regular clinic visits for imaging scans (like CT scans), blood tests, and physical examinations to check the cancer's status and their overall health.

3. Complete questionnaires about their quality of life.

4. Provide tumor tissue and blood samples for exploratory research to understand which patients might benefit most from this treatment.

Treatment will continue until the cancer worsens, side effects become intolerable, the participant decides to withdraw, or the study ends.

• Phase: PHASE2

Details

• Lead Sponsor: Zhijie Wang
• Collaborators: Hebei Medical University Fourth Hospital; Peking University Cancer Hospital & Institute
• Treatments: 130-nm albumin-bound paclitaxel; anlotinib; Carboplatin