Relatrilfa-α Plus Single-Agent Chemotherapy as Neoadjuvant Therapy for Resectable Stage II-III NSCLC (Phase 2)

NCT07550920 | Not Yet Recruiting Phase 2

• 1 other identifier: NSCLC-NEO-001
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a single-center, single-arm, phase 2 trial evaluating the efficacy and safety of retlirafusp alfa combined with single-agent chemotherapy as neoadjuvant treatment for patients with resectable stage II-III EGFR/ALK wild-type non-small cell lung cancer (NSCLC).Eligible patients receive 4 cycles of neoadjuvant therapy, followed by curative surgery and 1-year maintenance therapy with retlirafusp alfa.Primary endpoints are pathological complete response (pCR) rate and safety. Secondary endpoints include major pathological response (MPR), event-free survival (EFS), and overall survival (OS).

Conditions

NSCLC

Outcome Measures

Primary Outcomes (1)

• Pathological Complete Response (pCR) Rate

  Assessed at the time of surgery, approximately 6-8 weeks after completion of neoadjuvant therapy.

Secondary Outcomes (12)

• Major Pathological Response (MPR) Rate

  Assessed at the time of surgery.

• Event-Free Survival (EFS)

  Assessed from randomization up to 36 months post-surgery.

• Overall Survival (OS)

  From the start of randomization until the study end date (expected January 30, 2028)

• Pathological Response (PR) Rate

  Assessed at the time of surgery.

• R0 resection rate

  Assessment within 24 hours after surgery

Study Arms (1)

Experimental: Retlirafusp alfa + Single-agent Chemotherapy

EXPERIMENTAL

Drug: Drug: Retlirafusp alfa; Drug: Drug: Single-agent Chemotherapy; Other: Procedure: Radical Surgery

Interventions

Drug: Retlirafusp alfa DRUG

30mg/kg intravenously every 3 weeks (Q3W) for neoadjuvant and maintenance therapy

Experimental: Retlirafusp alfa + Single-agent Chemotherapy

Drug: Single-agent Chemotherapy DRUG

Nab-paclitaxel or pemetrexed (per histology), intravenously Q3W

Experimental: Retlirafusp alfa + Single-agent Chemotherapy

Procedure: Radical Surgery OTHER

Radical resection of lung cancer after neoadjuvant therapy

Experimental: Retlirafusp alfa + Single-agent Chemotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-75 years
• ECOG Performance Status 0-1;
• Treatment-naive patients with histologically or cytologically confirmed NSCLC (via biopsy) and radiologically confirmed Stage II-III disease;
• Patients with adenocarcinoma must be confirmed to be free of driver gene mutations such as EGFR or ALK; patients with squamous cell carcinoma do not require genetic testing;
• Patients must have measurable lesions;
• Patients whose disease was assessed as CR, PR, or SD following 2 cycles of neoadjuvant chemotherapy with Rilpufan α in combination with a single-agent non-platinum chemotherapy;
• Life expectancy of at least 12 weeks;
• Good function of other major organs (liver, kidneys, hematopoietic system, etc.): - Hemoglobin ≥ 9.0 g/dL (this level may be maintained or exceeded through blood transfusion); - Red blood cell count ≥ 2.0 × 10⁹/L; - Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹/L; - Platelet count ≥ 100 × 10⁹/L; - Total bilirubin within normal limits; - Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase ≤ 2.5 times the upper limit of normal; - Creatinine ≤ 2.0 mg/dL; and creatinine clearance ≥ 60 mL/min; - For patients who have not received anticoagulant therapy: International Normalized Ratio (INR) for prothrombin time ≤ 1.5, and activated partial thromboplastin time (APTT) ≤ 1.5 times the upper limit of normal. Patients receiving full-dose or parenteral anticoagulant therapy may be enrolled in the clinical trial provided that the anticoagulant dose has been stable for at least 2 weeks prior to study entry and the results of coagulation tests fall within the limits established by the local treatment center.
• No systemic metastases;
• Expected to be completely resectable;
• Good pulmonary function sufficient to tolerate surgical treatment;
• Women of childbearing potential must undergo a pregnancy test within 7 days prior to the start of treatment and receive a negative result;
• Participants must use reliable contraception (e.g., intrauterine device, oral contraceptives, and condoms) during the trial and for 30 days after its completion; 14 Participants voluntarily enroll in the study, sign an informed consent form, demonstrate good compliance, and cooperate with follow-up.

You may not qualify if:

• Patients who have had a cancer other than NSCLC within five years prior to the start of this trial;
• Patients with unstable systemic diseases, such as uncontrolled hypertension or severe arrhythmias;
• Patients with active, known, or suspected autoimmune diseases;
• Patients with a history of or current interstitial lung disease;
• Patients with HIV infection;
• Patients who have undergone major systemic surgery or suffered severe trauma within 2 months prior to the start of this trial;
• Pregnant or breastfeeding women;
• Patients with neurological or psychiatric disorders who are unable to comply with the study protocol;
• Other circumstances deemed unsuitable for enrollment by the investigator

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Central Study Contacts

Zhenfa Zhang Zhenfa Zhang

CONTACT

+8613821561246; zhangzhenfa1973@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 9, 2026
• First Posted: April 24, 2026
• Study Start (Estimated): May 10, 2026
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): January 30, 2028
• Last Updated: April 24, 2026

Record last verified: 2026-04