NCT07307443

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

Not yet recruiting Phase 2 Last updated 29 December 2025

What this trial tests

Phase 2 trial testing Anlotinib, nab-paclitaxel, carboplatin in SMARCA4-Deficient Tumor in 28 participants. Not yet recruiting.

Timeline

1 February 2026

Primary endpoint
1 December 2027

1 January 2028

Quick facts

Lead sponsor	Zhijie Wang
Phase	Phase 2
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	28
Start date	1 February 2026
Primary completion	1 December 2027
Estimated completion	1 January 2028
Sites	1 location across China

Drugs / interventions tested

• Anlotinib, nab-paclitaxel, carboplatin — full drug profile →

Conditions studied

• SMARCA4-Deficient Tumor — all drugs for SMARCA4-Deficient Tumor →
• Locally Advanced or Metastatic Lung Cancer — all drugs for Locally Advanced or Metastatic Lung Cancer →

Sponsor

Zhijie Wang — full company profile →

Who can join

18 and older, any sex, with SMARCA4-Deficient Tumor or Locally Advanced or Metastatic Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.