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The goal of this phase II, open-label, single-arm study is to evaluate the efficacy and safety of induction immunotherapy and chemotherapy followed by the multidisciplinary team (MDT)-guided radiotherapy or surgery in unresectable, stage III non-small cell lung cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional arm | Experimental | Patients will receive 3 cycles of induction therapy with sugemalimab and chemotherapy before curative local therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sugemalimab and Chemotherapy | Drug | Chemotherapy: Paclitaxel 175mg/m2 D1, Carboplatin AUC=5 or DDP 75mg/m2 D1 for NSCLC; Pemetrexed 500mg/m2 D1, Carboplatin AUC=5 or DDP 75mg/m2 D1 for non-squamous NSCLC; intravenous infusion every 3 weeks, for up to four cycles. Sugemalimab: 1200 mg by intravenous infusion every 3 weeks, for up to 2 years. |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective response rate | From the initiation of the first dose to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| PFS | Progression-free survival | From the initiation of the first dose to 3 years |
| OS | Overall survival | From the initiation of the first dose to 3 years |
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Inclusion Criteria:
1.18 to 75 years old, both male and female;
2.ECOG score: 0-1;
3.Histopathologically or cytologically confirmed, stage III (AJCC 8th) non-small cell lung cancer;
4.Multidisciplinary team (MDT) discussion confirmed unresectable disease but can be treated by curative radiotherapy;
5.Measurable lesions available;
6.Major organ function is basically normal;
7.Estimated survival time is at least 6 months;
8.Non-surgically sterile female subjects of childbearing age must have a negative serum HCG test before inclusion.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huai Liu, MD | Contact | +8619918909231 | liuhuai@hnca.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Hui Wang, MD | the Department of Radiation Oncology | Principal Investigator |
| Huai Liu, MD | the Department of Radiation Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan Cancer Hospital | Recruiting | Changsha | China |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C000723018 | sugemalimab |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| iORR | Objective response rate after induction therapy | From the initiation of the first dose to 3 years |
| AEs | Adverse events | From the initiation of the first dose to 90 days after the last dose |
| Measurement of Quality of Life with EORTC QLQ-C30 questionnaire | EORTC QLQ-C30 questionnaire minimum value: not at all (1); maximum: very much (4); higher scores means a worse outcome | From the initiation of the first dose to 3 years |
| Measurement of Quality of Life with EORTC QLQ-LC13 questionnaire | EORTC QLQ-LC13 questionnaire minimum value: not at all (1); maximum: very much (4); higher scores means a worse outcome | From the initiation of the first dose to 3 years |
| Measurement of Quality of Life with EORTC EQ-5D-5L VAS questionnaire | The EQ-5D-5L VAS records the respondent's self-rated health on a 10 centimeter (cm) vertical, visual analogue scale. It is rated by the respondent on a scale 0 to 100, with 0 being "the worst health you can imagine" and 100 being "the best health you can imagine" | From the initiation of the first dose to 3 years |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |