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The anti-tumor activity of anti-PD-1 therapy and VEGF inhibitor in TKI-resistant EGFR-mutated non-squamous NSCLC Chinese patients will be investigated in this clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sintilimab +IBI305+Pemetrexed+Cisplatin | Experimental | Drug: Sintilimab 200mg IV Q3W Other Name: IBI308 Drug: IBI305 15mg/kg IV Q3W Drug: Pemetrexed 500mg/m2 IV Q3W Drug: Cisplatin 75mg/m2 IV Q3W |
|
| Sintilimab +Placebo2+Pemetrexed+Cisplatin | Experimental | Drug: Sintilimab 200mg IV Q3W Other Name: IBI308 Drug: Pemetrexed 500mg/m2 IV Q3W Drug: Cisplatin 75mg/m2 IV Q3W Drug: Placebo2 Placebo2 IV Q3W |
|
| Placebo1+Placebo2+Pemetrexed+Cisplatin | Active Comparator | Drug: Pemetrexed 500mg/m2 IV Q3W Drug: Cisplatin 75mg/m2 IV Q3W Drug: Placebo1 Placebo1 IV Q3W Drug: Placebo2 Placebo2 IV Q3W |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sintilimab | Drug | 200mg IV Q3W |
|
| Measure | Description | Time Frame |
|---|---|---|
| PFS (Progression Free Survival) | Time from randomization to first documented disease progression (radiographic) assessed by Independent Imaging Assessment Committee (IRRC) or death due to any cause. up to 24month |
| Measure | Description | Time Frame |
|---|---|---|
| OS (Overall Survival) | Time from randomization to the death of the subject due to any cause assessed up to 36 months. | |
| ORR (overall response rate) | The proportion of subjects who have a complete response (CR) or a partial response (PR) assessed up to 24 months. |
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Main Inclusion Criteria:
Exclusion criteria:
Squamous cell > 10%. If small cell types are present, the subject is not eligible for inclusion.;
Has previously received systemic anti-tumor treatment other than EGFR-TKI for or advanced non-squamous NSCLC (including cytotoxic chemotherapy for radiotherapy, do not include other systemic treatment for other cured tumors);
Has previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or any other stimulatory or inhibitory agents of T cell receptors (eg CTLA-4, OX-40, CD137);
Has received EGFR-TKI treatment within 2 weeks;
Diagnosed of immunodeficiency or has received systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drugs.
History of pneumonitis requiring steroid therapy or the presence of interstitial lung disease within 1 year prior to the first dose of study drugs;
Symptomatic central nervous system metastases (CNS) metastasis and/or cancerous meningitis.
Hemoptysis within 3 months,
Full-dose oral or parenteral anticoagulant or thrombolytic agent for 10 consecutive days within 2 weeks. prophylactic use of anticoagulants is allowed;
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Chest Hospital | Shanghai | Shanghai Municipality | 200030 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37156249 | Derived | Lu S, Wu L, Jian H, Cheng Y, Wang Q, Fang J, Wang Z, Hu Y, Han L, Sun M, Miao L, Ding C, Cui J, Wang K, Li B, Li X, Ye F, Liu A, Pan Y, Cang S, Zhou H, Sun X, Shen Y, Wang S, Zhang W, He Y. Sintilimab plus chemotherapy for patients with EGFR-mutated non-squamous non-small-cell lung cancer with disease progression after EGFR tyrosine-kinase inhibitor therapy (ORIENT-31): second interim analysis from a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet Respir Med. 2023 Jul;11(7):624-636. doi: 10.1016/S2213-2600(23)00135-2. Epub 2023 May 5. | |
| 35908558 |
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| IBI305 | Drug | 15mg/kg IV Q3W |
|
| Pemetrexed | Drug | 500mg/m2 IV Q3W |
|
| Cisplatin | Drug | 75mg/m2 IV Q3W |
|
| Placebo1 | Drug | Placebo1 IV Q3W |
|
| Placebo2 | Drug | Placebo2 IV Q3W |
|
| PFS (Progression Free Survival) | Time from randomization to first documented disease progression (radiographic) assessed by investigator or death due to any cause up to 24 month. |
| DCR(Disease control rate ) | The proportion of subjects in the analysis population who had a complete response (CR) or partial response (PR) or stable disease (SD) up to 24 month. |
| TTR(Time to objective response ) | For subjects with CR or PR, defined as the time from randomization to the first documented CR or PR up to 24 month. |
| DOR(Duration of response) | For subjects with CR or PR, defined as the time from the first documented CR or PR to disease progression or death up to 24 month. |
| Derived |
| Lu S, Wu L, Jian H, Chen Y, Wang Q, Fang J, Wang Z, Hu Y, Sun M, Han L, Miao L, Ding C, Cui J, Li B, Pan Y, Li X, Ye F, Liu A, Wang K, Cang S, Zhou H, Sun X, Ferry D, Lin Y, Wang S, Zhang W, Zhang C. Sintilimab plus bevacizumab biosimilar IBI305 and chemotherapy for patients with EGFR-mutated non-squamous non-small-cell lung cancer who progressed on EGFR tyrosine-kinase inhibitor therapy (ORIENT-31): first interim results from a randomised, double-blind, multicentre, phase 3 trial. Lancet Oncol. 2022 Sep;23(9):1167-1179. doi: 10.1016/S1470-2045(22)00382-5. Epub 2022 Jul 28. |
| ID | Term |
|---|---|
| C000632826 | sintilimab |
| D000068437 | Pemetrexed |
| D002945 | Cisplatin |
| 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 |
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