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This is a prospective, multi-center, single arm study assessing the efficacy and safety of durvalumab given concurrently with platinum-based CRT (durvalumab + SoC CRT) in patients with locally advanced, unresectable NSCLC (Stage III).
Approximately 35 patients with locally advanced, unresectable NSCLC (Stage III) who are eligible to receive platinum-based CRT will be enrolled in and receive durvalumab + SoC CRT. Patients with CR, partial response (PR), or stable disease (SD）based on Investigator assessment at the 16-week tumor evaluation following completion of SoC CRT will continue to receive durvalumab as consolidation treatment. Patients with RECIST 1.1-defined radiological progressive disease (PD) will proceed to follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Durvalumab + platinum-based chemotherapy and radiation | Experimental | All patients will receive 1 of the following platinum-based standard of care chemotherapy options, based on Investigator discretion, in addition to radiation therapy: cisplatin/etoposide carboplatin/paclitaxel pemetrexed/cisplatin pemetrexed/carboplatin At the completion of standard of care chemoradiation therapy (SoC CRT), patients with complete response, partial response or stable disease will continue to receive durvalumab as consolidation treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Durvalumab | Drug | Durvalumab (intravenous infusion) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Grade ≥3 immune-mediated Adverse event | Grade ≥3 immune-mediated Adverse event | From the date of first dose until disease progression,assessed up to 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | Progression-free survival | From date of first dose until the date of objective disease progression or death,assessed up to 4 years |
| Overall Survival (OS) | Overall Survival |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Adverse events | From the date of enrollment until disease progression,assessed up to 4 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jinming Yu, professor | Contact | 15553181309 | yujinming@126.com | |
| Feifei Teng, physician | Contact | 13075305460 | tengfeifei16@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Cancer Hospital | Recruiting | Zhengzhou | Henan | 450000 | China |
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| Carboplatin/ Paclitaxel | Drug | Carboplatin /Paclitaxel, as per standard of care |
|
| Pemetrexed/ Cisplatin | Drug | Pemetrexed / Cisplatin, as per standard of care |
|
| Pemetrexed/ Carboplatin | Drug | Pemetrexed / Carboplatin , as per standard of care |
|
| Radiation | Radiation | 5 fractions/ week for ~6 weeks (±3 days) (Total 60 Gy) |
|
| From the date of first dose until death due to any cause,assessed up to 4 years |
| Objective response rate(ORR) | Objective response rate | From the date of first dose until the date of objective disease progression or death,assessed up to 4 years |
| Duration of response(DOR) | Duration of response | From the date of first documented response (RECIST 1.1.) until the first date of documented progression or death in the absence of disease progression,assessed up to 4 years |
| Disease control rate(DCR) | Disease control rate | From the date of first dose until 24 weeks. |
| Time to death or distant metastasis(TTDM) | Time to death or distant metastasis | From the date of first dose to until the first date of distant metastasis or death in the absence of distant metastasis,assessed up to 4 years |
| Shanghai Pulmonary Hospital | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
|
| ID | Term |
|---|---|
| C000613593 | durvalumab |
| C053518 | CP protocol |
| D000068437 | Pemetrexed |
| D002945 | Cisplatin |
| D016190 | Carboplatin |
| D011827 | Radiation |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017672 | Nitrogen Compounds |
| D017671 | Platinum Compounds |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D055585 | Physical Phenomena |
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