Clinical trial · Interventional
A Trial of SHR-1316/Placebo in Combination With Chemotherapy in Patients With Resectable NSCLC
A Randomized, Double-Blind, Multicenter, Phase Ib/III Clinical Study on PD-L1 Monoclonal Antibody SHR-1316 or Placebo in Combination With Chemotherapy as Perioperative Treatment of Resectable Stage II or III Non-Small Cell Lung Cancer
- 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 trial is designed to evaluate the efficacy, safety and immunogenicity of neoadjuvant treatment with monoclonal antibody SHR-1316 or placebo in combination with platinum doublet chemotherapy in participants with resectable Stage II, IIIA, or selected IIIB non-small cell lung cancer (NSCLC) followed by adjuvant SHR-1316 or placebo and monitoring.
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 |
|---|---|---|---|
| Non-Small-Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo、Chemotherapeutic | Drug | — | UNRESOLVED |
| SHR-1316、Chemotherapeutic | Drug | — | UNRESOLVED |
| SHR-1316、Paclitaxel (Albumin Bound)、Carboplatin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Treatment group A
- description
- Neoadjuvant setting: Drug: SHR-1316 and carboplatin and Paclitaxel (Albumin Bound) 3 cycles; Adjuvant setting: Drug: SHR-1316 up to 16 cycles
- interventionNames
- Drug: SHR-1316、Paclitaxel (Albumin Bound)、Carboplatin
- type
- EXPERIMENTAL
- label
- Treatment group B
- description
- Neoadjuvant setting: Drug: SHR-1316 and platinum-based dual chemotherapy 3 cycles; Adjuvant setting: Drug: SHR-1316 up to 16 cycles
- interventionNames
- Drug: SHR-1316、Chemotherapeutic
- type
- PLACEBO_COMPARATOR
- label
- Treatment group C
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Have previously untreated, pathologically confirmed resectable Stage II, IIIA, or Selected IIIB NSCLC. Staging should be based on the 8th edition of the AJCC/UICC staging system * Evaluation by an attending thoracic surgeon to confirm eligibility for an R0 resection with curative intent * Adequate tumor tissue sample blocks for central programmed death-ligand 1 (PD-L1) testing * Measurable disease as defined by RECIST v1.1 * Adequate organ function * Women of childbearing age without sterilizing or male, must agree to use contraception or practice abstinence at least 180 days after the last dose of study treatment Exclusion Criteria: * Any previous systematic anti-cancer therapy for lung cancer * With active, known or suspected autoimmune disease of autoimmune disease * Malignancies other than NSCLC within 5 years prior to randomization * Has or suspected has a history of pneumonitis /interstitial lung disease or any serve lung diseases which will influence the examination of lung function * Significant history of cardiovascular and cerebrovascular disease * Significant haemorrhagic disease * Has an arteriovenous thrombotic events * Has a known history of human immunodeficiency virus (HIV) infection * Has a known active Hepatitis B or Hepatitis C * Allergic to monoclonal antibodies or other protein drugs * Allergic to the intervention regimens * Pregnant or lactating women * Has known psychiatric or substance abuse disorders * Confirmed COVID-19 infection or suspected COVID-19 infection or close contact with a person with known or suspected COVID-19 infection.
References
Publications (0)
Data not yet available