Anlotinib after surgery for non-pCR non-small cell lung cancer

To Evaluate the Efficacy and Safety of Anlotinib Hydrochloride Capsule in Postoperative Non-pCR Patients With Non-small Cell Lung Cancer

This will test whether taking anlotinib capsules after surgery helps people with stage IIA–IIIA non-small cell lung cancer who did not have a complete pathological response after preoperative chemo‑immunotherapy.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Tianjin Medical University Cancer Institute and Hospital (Academic / other)
• Drugs / interventions: chemotherapy, anlotinib
• Locations: 1 site (Tianjin)
• Trial ID: NCT06352008 on ClinicalTrials.gov

What this trial studies

This is a phase 2 interventional trial giving anlotinib as adjuvant therapy to patients with stage IIA–IIIA non‑small cell lung cancer who received neoadjuvant PD‑1/PD‑L1 inhibitor plus chemotherapy and underwent R0 resection but did not achieve a pathological complete response. Eligible patients start oral anlotinib 4–12 weeks after surgery and are monitored for safety and signs of cancer recurrence. The study will collect clinical outcomes such as disease‑free survival and record adverse events to characterize tolerability in this postoperative setting. Results will inform whether anlotinib can reduce recurrence risk in this higher‑risk subgroup.

Who should consider this trial

Good fit: Adults (≥18) with stage IIA–IIIA NSCLC who received neoadjuvant PD‑1/PD‑L1 plus chemotherapy, had R0 resection but did not achieve pathological complete response, have ECOG 0–1, adequate organ function, and can start treatment 4–12 weeks after surgery are ideal candidates.

Not a fit: Patients with a pathological complete response, those with poor organ function or ECOG >1, those unable to begin treatment within 4–12 weeks postoperatively, or those with disease outside the specified stages are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, anlotinib could lower the risk of cancer coming back and extend disease‑free survival for non‑pCR patients after surgery.

How similar studies have performed: Anlotinib has shown activity and survival benefit in later‑line NSCLC, but its use as adjuvant therapy after neoadjuvant chemo‑immunotherapy in non‑pCR patients is largely novel and not yet established.

Eligibility criteria

Inclusion Criteria:

1. The subjects voluntarily joined the study, signed the informed consent, and the compliance was good;
2. ≥18 years old (calculated by the date of signing the informed consent); Both men and women; ECOG score 0\~1; Expected survival ≥3 months;
3. Patients with stage IIA-IIIA NSCLC who had previously received PD-1/PD-L1 inhibitors combined with chemotherapy neoadjuvant therapy and underwent R0 resection for curative purposes before surgery (note: the disease was presented in the American Joint Committee on Cancer (AJCC)/Union International Against Cancer (UICC) 8th edition of lung cancer TNM staging);
4. For patients who did not achieve pathological complete response after PD-1/PD-L1 inhibitor combined with chemotherapy neoadjuvant treatment, and the time between the first trial medication after surgery was required to be 4-12 weeks;
5. The main organs function well and meet the standards;
6. Women of reproductive age should agree that effective contraception must be used during the study period and for 6 months after the end of the study, and that serum or urine pregnancy tests are negative within 7 days prior to study enrollment; Men should agree that effective birth control must be used during the study period and for 6 months after the end of the study period.

Exclusion Criteria:

1. Have had or are currently suffering from other malignant tumors within 5 years. The following two conditions can be included: other malignancies treated with a single operation, achieving continuous 5-year disease-free survival (DFS); Cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors \[Ta (non-invasive tumor), Tis (cancer in situ) and T1 (tumor infiltrating basal membrane)\];
2. Subjects are known to have genetic abnormalities that have been approved for targeted drug therapy (non-squamous cell carcinoma subjects are required to have EGFR or ALK gene tested or provide previous test reports during the screening period)
3. Cardiovascular and cerebrovascular abnormalities:

   1. Patients with past or existing heart failure, degree II or higher heart block;
   2. Past or present myocardial infarction or unstable angina pectoris, clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention;
   3. Occurrence of arteriovenous thrombosis/cancer embolus events within 6 months, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction requiring clear diagnosis), vascular embolism (including deep vein thrombosis, arterial thrombosis, pulmonary embolism, etc.);
4. Participated in other drug clinical trials within the past 30 days;
5. Within 2 weeks before starting the administration, it has been treated with Chinese patent medicines (including compound Cantharides capsule, Kangai injection, Kanglaite capsule/injection, Aidi injection, Bruceae oil injection/capsule, Xiaoaipingtablet/injection, hualbufatin capsule, etc.) with anti-tumor indications specified in the NMPA approved drug instructions;
6. Received major surgery other than radical resection of lung cancer within 4 weeks prior to initiation of administration; According to the investigator, the patient was not eligible to participate in this clinical study for other reasons.

Where this trial is running

Tianjin

• Tianjin Medical University Cancer Institute & Hospital — Tianjin, China (Recruiting)

Study contacts

• Study coordinator: Zhansheng

Conditions Non-Small Cell Lung Cancer