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.
Voluntary participation and provision of written informed consent.
Age ≥ 18 years.
Life expectancy ≥ 3 months.
Diagnosed with unresectable, locally advanced (Stage IIIB) or metastatic (Stage IV) lung cancer not amenable to curative radiotherapy.
Pathological diagnosis containing a small cell carcinoma component.
Symptomatic brain metastases.
Leptomeningeal carcinomatosis.
Failure to recover from acute toxicities of prior anti-cancer therapy to ≤ Grade 1 per NCI CTCAE v5.0 or to baseline levels specified in the inclusion criteria (excluding alopecia or fatigue) within 4 weeks prior to the first dose.
Zhijie Wang
Lead sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Sponsor institution
Hebei Medical University Fourth Hospital
Collaborator
Peking University Cancer Hospital & Institute
Collaborator