To explore and evaluate the safety and efficacy of camrelizumab combined with chemotherapy ± thalidomide in first-line treatment of advanced non-small cell lung cancer patients
Age ≥18 years old, both male and female.
Histopathology or cytology confirmed advanced Stage IIIB-IV non-small cell lung cancer.
No prior systemic treatment to advanced NSCLC . Subjects who have received prior neo-adjuvant, adjuvant chemotherapy, or chemoradiotherapy with curative intent for non-metastatic disease must have experienced a treatment free interval of at least 12 months from randomization since the last chemotherapy cycle.
Subjects must have measurable disease by CT or MRI per RECIST 1.1 criteria.
Female Subjects of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose, are not breastfeeding, and must be willing to use very efficient barrier methods of contraception for the course of the study through 180 days after the last dose of study treatment. Male subjects whose partners are fertile women should be surgically sterilized or agree to use effective contraception during the trial period and 90 days after the last administration of the study drug, and sperm donation is not allowed during the study period.
Subjects has voluntarily agreed to participate by giving written informed consent. Willing and able to follow planned visits, research treatments, laboratory tests and other test procedures.
Patients with non-small cell lung cancer diagnosed with other histopathological types, including patients with NSCLC containing small cell lung cancer components.
Subjects with epidermal growth factor receptor (EGFR)-sensitizing mutation and/or anaplastic lymphoma kinase (ALK) translocation.
Sequential
Camrelizumab + chemotherapy+Thalidomide
DrugCamrelizumab + chemotherapy+Thalidomide Drug: Camrelizumab Camrelizumab 200mg intravenous (IV) on Day 1 of each 21-day cycle，until progression or unacceptable toxicity Other Name: SHR-1210 Drug: Thalidomide Thalidomide 100mg，po qd； Other Name: Thalidomide Drug: Chemotherapy Platinum-based chemotherapy: Non-small cell lung cancer (non-squamous cell carcinoma): pemetrexed plus carboplatin/cisplatin on Day 1 of each 21-day cycle for 4-6 cycles，pemetrexed every three weeks (Q3W) maintenance for the remainder of the study or until documented PD; Non-small cell lung cancer (squamous cell carcinoma) : paclitaxel/albumin-bound paclitaxel + carboplatin/cisplatin on Day 1 of each 21-day cycle for 4-6 cycles. Other Name: Platinum-based chemotherapy
Camrelizumab + chemotherapy+placebo
DrugDrug: Camrelizumab Camrelizumab 200mg intravenous (IV) on Day 1 of each 21-day cycle，until progression or unacceptable toxicity Other Name: SHR-1210 Drug: placebo 100mg placebo 100mg，po qd； Drug: Chemotherapy Platinum-based chemotherapy: Non-small cell lung cancer (non-squamous cell carcinoma): pemetrexed plus carboplatin/cisplatin on Day 1 of each 21-day cycle for 4-6 cycles，pemetrexed every three weeks (Q3W) maintenance for the remainder of the study or until documented PD; Non-small cell lung cancer (squamous cell carcinoma) : paclitaxel/albumin-bound paclitaxel + carboplatin/cisplatin on Day 1 of each 21-day cycle for 4-6 cycles. Other Name: Platinum-based chemotherapy
Incidence rate of any grade Reactive Cutaneous Capillary Endothelial Proliferation(RCCEP)
Incidence rate of any grade Reactive Cutaneous Capillary Endothelial Proliferation(RCCEP)
Median time to RCCEP
Median time to RCCEP
Median time to RCCEP of level 3 or above
Median time to RCCEP of level 3 or above
Incidence rate of ≥G3 grade RCCEP
Incidence rate of ≥G3 grade RCCEP
Overall Response Rate (ORR)
Overall Response Rate (ORR)
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Tongji University
Lead sponsor
Dongfang Hospital Affiliated to Tongji University
Sponsor institution
Shanghai Pulmonary Hospital, Shanghai, China
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
