Clinical trial · Interventional
Induction Therapy With PD-1 Antibody Combined With Platinum-based Doublet Chemotherapy for Locally-advanced Non-small Cell Lung Cancer
Induction Therapy With PD-1 Antibody Combined With Platinum-based Doublet Chemotherapy for Locally-advanced Non-small Cell Lung Cancer: A Randomised Controlled, Open-label, Phase 2 Trial
- 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)
For unresectable locally-advanced non-small cell lung cancer, chemoradiotherpay plus immunotherapy is recommended by PACIFIC trial. However, it is unclear whether surgery can provide survival benefit for patients with tumors initially unresectable transformed into resectable ones after chemoimmunotherapy. This trial aims to investigate the efficacy and safety of the therapeutic regimen of chemoimmunotherapy plus surgery.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced | — | UNRESOLVED | — |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carboplatin | Drug | Carboplatin | ALIAS |
| Liposomal paclitaxel | Drug | Paclitaxel Liposome | ALIAS |
| Nab-paclitaxel | Drug | Nab-paclitaxel | ALIAS |
| Pemetrexed | Drug | Pemetrexed | ALIAS |
| Radiotherapy | Radiation | — | UNRESOLVED |
| Serplulimab | Drug | Serplulimab | ALIAS |
| Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Downstaged arm with surgical treatment
- description
- In this arm, patients with tumors resectable after chemoimmunotherapy will receive surgical treatment in department of thoracic surgery.
- interventionNames
- Drug: Serplulimab
- Drug: Carboplatin
- Drug: Pemetrexed
- Drug: Nab-paclitaxel
- Drug: Liposomal paclitaxel
- Procedure: Surgery
- type
- ACTIVE_COMPARATOR
- label
- Downstaged arm with radiotherapy
- description
- In this arm, patients with tumors resectable after chemoimmunotherapy will receive radiotherapy in department of medical oncology.
- interventionNames
- Drug: Serplulimab
- Drug: Carboplatin
- Drug: Pemetrexed
- Drug: Nab-paclitaxel
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. The patient shall sign the Informed Consent Form. 2. Aged 18 ≥ years. 3. Histological or cytological diagnosis of NSCLC by needle biopsy, and stage IIIB-IIIC confirmed by imageological examinations (CT, PET-CT or EBUS). 4. Eastern Cooperative Oncology Group (ECOG) performance-status score of 0 or 1. 5. Life expectancy is at least 12 weeks. 6. At least 1 measurable lesion according to RECIST 1.1. 7. Patients with good function of other main organs (liver, kidney, blood system, etc.) 8. Patients with normal lung function can tolerate surgery; 9. Without systematic metastasis (including M1a, M1b and M1c); 10. Fertile female patients must voluntarily use effective contraceptives not less than 120 days after chemotherapy or the last dose of Serplulimab (whichever is later) during the study period, and urine or serum pregnancy test results within 7 days prior to enrollment are negative. 11. Unsterilized male patients must voluntarily use effective contraception during the study period not less than 120 days after chemotherapy or the last dose of Serplulimab (whichever is later). Exclusion Criteria: 1. Participants who have received any systemic anti-cancer treatment for thymic epithelial tumor, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment; 2. Participants with any unstable systemic disease (including active infection, uncontrolled hypertension), unstable angina pectoris, angina pectoris starting in the last three months, congestive heart failure (\>= NYHA) Grade II), myocardial infarction (6 months before admission), severe arrhythmia requiring drug treatment, liver, kidney or metabolic diseases; 3. With activate or suspectable autoimmune disease, or autoimmune paracancer syndrome requiring systemic treatment; 4. Participants who are allergic to the test drug or any auxiliary materials; 5. Participants with Interstitial lung disease currently; 6. Participants with active hepatitis B, hepatitis C or HIV; 7. Pregnant or lactating women; 8. Participants suffering from nervous system diseases or mental diseases that cannot cooperate; 9. Participated in another therapeutic clinical study; 10. Other factors that researchers think it is not suitable for enrollment.
References
Publications (0)
Data not yet available