Advanced or Metastatic Non-squamous Non-small-cell Lung Cancer
Conditions
Brief summary
Evaluate efficacy and safety of SHR-1701 in combination with bevacizumab and chemotherapy in advanced or metastatic non-squamous non-small-cell lung cancer with EGFR mutation after failure of TKIs
Interventions
DRUGSHR-1701 + Pemetrexed Disodium + cisplatin/carboplatin + bevacizumab
SHR-1701 + Pemetrexed Disodium + cisplatin/carboplatin + bevacizumab
DRUGPlacebo + SHR-1701 + Pemetrexed Disodium+ cisplatin/carboplatin
Placebo + SHR-1701 + Pemetrexed Disodium+ cisplatin/carboplatin
DRUGPlacebo 1 + Placebo 2 +Pemetrexed Disodium + cisplatin/carboplatin
Placebo 1 + Placebo 2 +Pemetrexed Disodium + cisplatin/carboplatin
Sponsors
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
SHR-1701/ Placebo Plus Chemotherapy With or Without Bevacizumab
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
\- A subject must satisfy all of the following criteria to be considered for inclusion in the study: 1. Histologically or cytologically confirmed advanced or metastatic non-squamous non-small cell lung cancer. 2. Failed with prior EGFR-TKIs treatments. 3. Measurable disease, as defined by RECIST v1.1 4. The Eastern Cancer Cooperative Group (ECOG) performance status of 0 or 1 5. Life expectancy ≥ 3 months 6. Adequate hematologic and end-organ function as defined in the protocol
Exclusion criteria
\- A subject who meets any of the following criteria will be excluded from study entry: 1. Histologically or cytologically confirmed mixed SCLC and NSCLC. 2. Symptomatic, untreated or active central nervous system metastases. 3. Systemic therapy with immunosuppressive agents within 2 weeks prior to initiation of study treatment 4. With any active autoimmune disease or history of autoimmune disease. 5. Inadequately controlled hypertension. 6. Tumour infiltration into the great vessels on imaging. 7. History of haemoptysis ≥2.5ml per episode within 1 month prior to initiation of study treatment. 8. Uncontrolled tumour-related pain. 9. Patients with active hepatitis B or hepatitis C 10. Severe infections within 4 weeks prior to initiation of study treatment. Active tuberculosis within one year prior to initiation of study treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and immune-related adverse events (irAEs) as per NCI-CTC AE 5.0 （Stage I） | 2 years |
| BIRC-assessed progression-free survival (PFS) as per RECIST v1.1（Stage II） | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Disease control rate (DCR) （Stage I） | 2 years |
| Duration of response (DOR) （Stage I） | 2 years |
| Overall survival (OS) （Stage I） | 2 years |
| Progression free survival (PFS)（Stage II） | 2 years |
| Objective response rate (ORR)（Stage II） | 2 years |
| Progression free survival (PFS)（Stage I） | 2 years |
| Duration of response (DOR) （Stage II） | 2 years |
| Overall survival (OS) （Stage II） | 2 years |
| Incidence and severity of adverse events (AEs), serious adverse events （Stage II） | 2 years |
| (SAEs), and immune-related adverse events (irAEs) as per NCI-CTC AE 5.0（Stage II） | 2 years |
| Disease control rate (DCR)（Stage II） | 2 years |
| Objective response rate (ORR)（Stage I） | 2 years |
Contacts
Primary ContactYuanchao Wang
Backup ContactYou Li
Outcome results
None listed