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The purpose of this study is to assess the efficacy and safety of Camrelizumab plus chemotherapy in the treatment of adult participants with medically inoperable Stage I or IIA non-small cell lung cancer (NSCLC).
This trial will evaluate the safety and efficacy of camrelizumab in combination with chemotherapy, followed by camrelizumab alone after 4-6 cycles of combination in participants with medically inoperable stage I or IIA non-small cell lung cancer (NSCLC). The primary objective of this pilot study is to determine the Camrelizumab plus chemotherapy improves progression-free survival (PFS) . All the efficacy and safety are assessed by investigator : 1) response rate (ORR), 2) disease control rate (DCR); 3) overall survival (OS), 4) PFS rate of 1-year, 2-year, and 5-year; and 5) OS rate of 1-year, 2-year, and 5-year.
Explore objective is potential biomarker associated with efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Camrelizumab combined with chemotherapy | Experimental | Participants receive camrelizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 18 cycles PLUS Investigator's choice of chemotherapy. Interventions: Biological: Camrelizumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biological: Camrelizumab | Drug | PD-1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) | PFS is determined by the Investigator Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). | up to approximately 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | OS is defined as the first date of treatment to date of death from any causes. | up to approximately 5 years |
| Objective response rate (ORR) | ORR is defined as the percentage of participants in the analysis population who have a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 by investigator. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Changli Wang, PhD | Contact | 86-22-23340123 | 6417 | wangchangli@medmail.com.cn |
| Lianming Zhang, PhD | Contact | 86-22-23340123 | 6417 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tianjin Medical University Cancer Institute and Hospital | Recruiting | Tianjin | 300060 | China |
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| ID | Term |
|---|---|
| C565324 | Parkinson Disease 4, Autosomal Dominant Lewy Body |
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| ID | Term |
|---|---|
| C000631724 | camrelizumab |
| D000068437 | Pemetrexed |
| C520255 | 130-nm albumin-bound paclitaxel |
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 |
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| Pemetrexed | Drug | chemotherapy |
|
|
| Nab-paclitaxel | Drug | chemotherapy |
|
|
| up to approximately 1 years |
| Disease Control Rate (DCR) | DCR is defined as the percentage of patients who have achieved complete response and partial response per RECIST 1.1 by investigator.. | up to approximately 3 years |
| Adverse Events (AEs) | The number of participants experiencing an AE will be assessed. | up to 18 months |
| PFS at 12 months (PFS12) | PFS will be calculated using Kaplan-Meier product limit methods. | up to maximum 12 months |
| PFS at 24 months (PFS24) | PFS will be calculated using Kaplan-Meier product limit methods. | up to maximum 24 months |
| PFS at 5 years | PFS will be calculated using Kaplan-Meier product limit methods. | up to maximum 5 years |
| OS at 12 months (OS12) | OS will be calculated using Kaplan-Meier product limit methods. | up to maximum 12 months |
| OS at 24 months (OS24) | OS will be calculated using Kaplan-Meier product limit methods. | up to maximum 24 months |
| OS at 5 years | OS will be calculated using Kaplan-Meier product limit methods. | up to maximum 5 years |
| 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 |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |