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| Name | Class |
|---|---|
| Shanghai Junshi Bioscience Co., Ltd. | OTHER |
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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
This study is a Phase II study to evaluate the clinical efficacy and safety of two cycles of induction Toripalimab plus chemotherapy followed by definitive chemoradiotherapy and consolidation Toripalimab therapy for large-volume, unresectable, locally advanced stage II-III non-small cell lung cancer ("large volume" is defined as primary tumor ≥5 cm in greatest dimension or metastatic lymph nodes ≥2 cm in shortest diameter).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Induction Toripalimab and chemotherapy followed by concurrent chemoradiotherapy | Experimental | 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. |
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| Induction chemotherapy followed by concurrent chemoradiotherapy | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toripalimab | Drug | Two cycles of induction Toripalimab (240mg every 3 weeks) plus platinum-based doublet chemotherapy as induction chemoimmunotherapy. |
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| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | Defined as the time from date of recruitment until the date of first documented progression or date of death from any cause, whichever came first. | From date of recruitment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS） | Defined as the time from recruitment to the date of any documented death due to any cause. | From recruitment to the date of any documented death due to any cause, assessed up to 36 months. |
| Adverse Event |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nan Bi, MD | Chinese Academy of Medical Science and Peking Union Medical College | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese Academy of Medical Science and Peking Union Medical College | Beijing | Beijing Municipality | 100021 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38288117 | Derived | Wang 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. |
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| Concurrent chemoradiation therapy and consolidation immunotherapy | Radiation | Thoracic radiation therapy (54-66Gy/25-33F/5-7week), concurrently with platinum-based doublet chemotherapy, followed by consolidation Toripalimab (240mg every 3 weeks) as consolidation immunotherapy for up to 12 months. |
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The incidence of adverse events (AEs) and serious adverse events (SAEs), evaluated by CTCAE 5.0. Appropriate description of AEs and laboratory data/vital signs will be produced. Number of patients who had at least one adverse event will be calculated.
| AEs and SAEs must be collected from the time that the main study informed consent is obtained to 28 days after discontinuation of study drug, up to 36 months. |
| Objective Tumour Response (ORR) | The objective tumour response (ORR) will be calculated as the number of patients with CR or PR per RECIST Criteria. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. | Tumor assessment using RECIST will be performed at baseline then every 42 days (6 weeks) ± 7 days (1 week) from recruitment until objective progression or death from any cause, assessed up to 36 months. |
| Disease control rate（DCR） | DCR will be calculated as the number of patients with CR, PR or sustained SD≥6 weeks per RECIST Criteria. Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase. | Tumour assessment using RECIST will be performed at baseline then every 42 days (6 weeks) ± 7 days (1 week) from randomisation until objective progression or death from any cause, assessed up to 36 months. |
| ID | Term |
|---|---|
| C000656314 | toripalimab |
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