Clinical trial · Interventional
Relatrilfa-α Plus Single-Agent Chemotherapy as Neoadjuvant Therapy for Resectable Stage II-III NSCLC (Phase 2)
Efficacy and Safety of Rilapentib Alpha Combined With Monotherapy Chemotherapy for the Perioperative Treatment of Resectable Stage II-III Driver Gene-Negative Non-Small Cell Lung Cancer (NSCLC): A Single-Center Phase II Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Drug: Retlirafusp alfa | Drug | — | UNRESOLVED |
| Drug: Single-agent Chemotherapy | Drug | — | UNRESOLVED |
| Procedure: Radical Surgery | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental: Retlirafusp alfa + Single-agent Chemotherapy
- interventionNames
- Drug: Drug: Retlirafusp alfa
- Drug: Drug: Single-agent Chemotherapy
- Other: Procedure: Radical Surgery
Primary outcomes (1)
- measure
- Pathological Complete Response (pCR) Rate
- timeFrame
- Assessed at the time of surgery, approximately 6-8 weeks after completion of neoadjuvant therapy.
Secondary outcomes (12)
- measure
- Major Pathological Response (MPR) Rate
- timeFrame
- Assessed at the time of surgery.
- measure
- Event-Free Survival (EFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * Any systemic anticancer therapy for NSCLC, other than neoadjuvant therapy as specified in the inclusion criteria, including surgery, local radiotherapy, cytotoxic drug therapy, targeted drug therapy, and experimental treatments; * 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
References
Publications (0)
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