Clinical trial · Interventional
Induction Chemotherapy and Toripalimab Followed by Chemoradiotherapy for Large-volume Local Advanced NSCLC
The Efficacy and Safety of Induction Chemotherapy and Toripalimab Followed by Chemoradiotherapy for Large-volume (Bulky) Local Advanced Non-small Cell Lung Cancer
NCT05888402CI-TRIAL-00104208InTRistactive not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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 study is a Phase II study to evaluate the clinical efficacy and safety of Toripalimab combined with chemoradiotherapy for large-volume local advanced non-small cell lung cancer
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 |
|---|---|---|---|
| Local Advanced Non-small Cell Lung Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Concurrent chemoradiation therapy and consolidation immunotherapy | Radiation | — | UNRESOLVED |
| Toripalimab | Drug | Toripalimab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Induction Toripalimab and chemotherapy followed by concurrent chemoradiotherapy
- description
- Participants will receive 2 cycles of induction therapy of platinum-based chemotherapy combined with Toripalimab, followed by platinum-based concurrent chemoradiation. Then participants will receive Toripalimab consolidation therapy after chemoradiotherapy with maximum 1 years or until disease progression or intolerable toxicity.
- interventionNames
- Drug: Toripalimab
- Radiation: Concurrent chemoradiation therapy and consolidation immunotherapy
- type
- ACTIVE_COMPARATOR
- label
- Induction chemotherapy followed by concurrent chemoradiotherapy
- description
- Participants will receive 2 cycles of induction platinum-based chemotherapy, followed by platinum-based concurrent chemoradiation. Then participants will receive Toripalimab consolidation therapy after chemoradiotherapy with maximum 1 years or until disease progression or intolerable toxicity.
- interventionNames
- Radiation: Concurrent chemoradiation therapy and consolidation immunotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18-75 years; ECOG score 0-1. 2. Histologically or cytologically confirmed non-small cell lung cancer (NSCLC). 3. Unresectable Stage II-III NSCLC (according to AJCC 8th edition) with maximum tumor diameter T ≥ 5 cm in the primary tumor or minimum diameter N ≥ 2 cm in mediastinal metastatic lymph nodes. 4. No other previous anti-tumor history, at least 3 months of expected survival. 5. No serious medical diseases and dysfunction of major organs, such as blood routine, liver, kidney, heart and lung function. Exclusion Criteria: 1. Pathologic type was adenocarcinoma with EGFR gene mutation or ALK gene rearrangement. 2. Patients with other active malignancies within 5 years or at the same time. 3. Active or previously documented autoimmune or inflammatory diseases (including inflammatory bowel disease, diverticulitis \[except diverticular disease\], systemic lupus erythematosus, Sarcoidosis syndrome, Wegener' s syndrome). 4. History of allogeneic organ transplantation. 5. History of active primary immunodeficiency. 6. Patients with uncontrolled concurrent diseases, including but not limited to persistent or active infection (including tuberculosis, hepatitis B, hepatitis C, human immunodeficiency virus, etc.), symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, uncontrolled arrhythmia, active interstitial lung disease, severe chronic gastrointestinal disease with diarrhea or mental illness. 7. Women of child-bearing potential who are pregnant or breastfeeding. 8. Allergic to research drug ingredients. 9. Ongoing or prior use of immunosuppressive agents within 14 days prior to first dose 10. The investigator judged other situations not suitable for inclusion in this study.
References
Publications (1)
- DERIVEDWang Y, Deng L, Wang J, Zhang T, Wang W, Wang X, Liu W, Wu Y, Lv J, Feng Q, Zhou Z, Wang J, Wang L, Wang Z, Bi N. Induction PD-1 inhibitor toripalimab plus chemotherapy followed by concurrent chemoradiotherapy and consolidation toripalimab for bulky locally advanced non-small-cell lung cancer: protocol for a randomized phase II trial (InTRist study). Front Immunol. 2024 Jan 15;14:1341584. doi: 10.3389/fimmu.2023.1341584. eCollection 2023. PMID 38288117