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.
Single group
Anlotinib, nab-paclitaxel, carboplatin
DrugParticipants will receive Anlotinib (12 mg, orally, once daily on days 1-14) in combination with nab-paclitaxel (260 mg/m², IV, administered as a single dose on day 1 or split between days 1 and 8) and carboplatin (AUC=4-5, IV, day 1) every 21 days for 4-6 induction cycles. Dose adjustments may be made based on clinical judgment and tolerability. Patients who do not experience disease progression or intolerable toxicity following the induction phase will proceed to maintenance therapy with Anlotinib monotherapy (12 mg, orally, once daily on days 1-14 every 21 days). Treatment will continue until disease progression, unacceptable toxicity, consent withdrawal, investigator decision, loss to follow-up, death, or meeting other protocol-defined criteria for discontinuation. The maximum duration of Anlotinib treatment is 24 months. Beyond this period, continuation will be at the investigator's discretion based on an individual benefit-risk assessment.
Progression-Free Survival (PFS)
PFS is defined as the time from the first dose of study treatment to the first documentation of disease progression according to RECIST v1.1 (as assessed by investigators) or death from any cause, whichever occurs first. Subjects who are alive without progression at the time of analysis will be censored at the date of the last tumor assessment.
Overall Survival (OS)
OS is defined as the time from the first dose of study treatment to death from any cause. Subjects who are alive at the time of analysis will be censored at the date of last follow-up.
Objective Response Rate (ORR)
ORR is defined as the proportion of subjects who achieve a complete response (CR) or partial response (PR) as per RECIST v1.1.
Duration of Response (DoR)
DoR is defined as the time from the first documentation of CR or PR to the first documentation of disease progression or death.
Disease Control Rate (DCR)
DCR is defined as the proportion of subjects who achieve CR, PR, or stable disease (SD) as their best overall response.
Biomarker Discovery
Collection of tumor tissue and peripheral blood samples at baseline and disease progression for multi-omics analysis (e.g., DNA, RNA) to characterize tumor and microenvironment features and identify potential biomarkers of treatment efficacy and toxicity.
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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
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