Camrelizumab, Lung Cancer
Conditions
Brief summary
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
Interventions
DRUGCamrelizumab + chemotherapy+Thalidomide
Camrelizumab + 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
DRUGCamrelizumab + chemotherapy+placebo
Drug: 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
Sponsors
Shanghai Pulmonary Hospital, Shanghai, China
Tongji University
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years old, both male and female. 2. Histopathology or cytology confirmed advanced Stage IIIB-IV non-small cell lung cancer. 3. 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. 4. Subjects must have measurable disease by CT or MRI per RECIST 1.1 criteria. 5. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1. 6. Have a life expectancy of at least 3 months. 7. All baseline laboratory requirements will be assessed. 8. Can swallow pills normally. 9. Remission of all acute toxic reactions to previous antitumor therapy to grade 0-1 or to the level specified in the
Exclusion criteria
. 10. 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. 11. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence rate of any grade Reactive Cutaneous Capillary Endothelial Proliferation(RCCEP) | 2 years | Incidence rate of any grade Reactive Cutaneous Capillary Endothelial Proliferation(RCCEP) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median time to RCCEP of level 3 or above | 2 years | Median time to RCCEP of level 3 or above |
| Incidence rate of ≥G3 grade RCCEP | 2 years | Incidence rate of ≥G3 grade RCCEP |
| Overall Response Rate (ORR) | 2 years | Overall Response Rate (ORR) |
| Median time to RCCEP | 2 years | Median time to RCCEP |
| Overall Survival(OS) | 2 years | Overall Survival(OS) |
| Treatment-related Adverse Events (TRAE) | 2 years | Treatment-related Adverse Events (TRAE) |
| Progression-Free Survival (PFS) | 2 years | Progression-Free Survival (PFS) |
Contacts
Primary ContactAnwen Xiong, MD
Outcome results
None listed