Non-Squamous Non-Small Cell Lung Cancer
Conditions
Brief summary
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.
Interventions
Sponsors
Innovent Biologics (Suzhou) Co. Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Main Inclusion Criteria: 1. Signed written informed consent before any trial-related processes; 2. Age ≥ 18 years and \<75 years male or females; 3. Has a histologically or cytologically confirmed stage IIIB/IIIC (American Joint Committee on Cancer \[AJCC\] 8th edition) NSCLC that is unresectable and not fit for radical concurrent chemoradiotherapy, or metastatic / recurrent non-squamous NSCLC; 4. Patients with EGFR mutation confirmed by tumor histology or cytology or hematology prior to EGFR-TKI treatment 5. EGFR-TKI resistance, confirmed by RECIST 1.1 6. The investigator confirms at least one measurable lesion according to RECIST 1.1. A measurable lesion located in the field of previous radiation therapy or after local treatment may be selected as a target lesion if progression is confirmed; The Eastern Cancer Cooperative Group (ECOG) performance score of 0 or 1;
Exclusion criteria
1. Squamous cell \> 10%. If small cell types are present, the subject is not eligible for inclusion.; 2. 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); 3. 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); 4. Has received EGFR-TKI treatment within 2 weeks; 5. 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. 6. History of pneumonitis requiring steroid therapy or the presence of interstitial lung disease within 1 year prior to the first dose of study drugs; 7. Symptomatic central nervous system metastases (CNS) metastasis and/or cancerous meningitis. Hemoptysis within 3 months, 8. Full-dose oral or parenteral anticoagulant or thrombolytic agent for 10 consecutive days within 2 weeks. prophylactic use of anticoagulants is allowed;
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | Time frame |
|---|---|
| ORR (overall response rate) | The proportion of subjects who have a complete response (CR) or a partial response (PR) assessed up to 24 months. |
| 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. |
| OS (Overall Survival) | Time from randomization to the death of the subject due to any cause assessed up to 36 months. |
| 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. |
| 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. |
Countries
China
Outcome results
None listed