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

NCT07307443 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2025-12-29

No results posted yet for this study

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.

Conditions

  • SMARCA4-Deficient Tumor
  • Locally Advanced or Metastatic Lung Cancer

Interventions

DRUG

Anlotinib, nab-paclitaxel, carboplatin

Participants 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.

Sponsors & Collaborators

  • Hebei Medical University Fourth Hospital

    collaborator OTHER

  • Peking University Cancer Hospital & Institute

    collaborator OTHER

  • Zhijie Wang

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-01
Primary Completion
2027-12-01
Completion
2028-01-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07307443 on ClinicalTrials.gov