CompletedPhase 3

Efficacy and Safety Evaluation of Sintilimab in Patients With Advanced or Metastatic Non-squamous NSCLC

China397 participantsStarted 2018-08-23

Plain-language summary

Efficacy and Safety Evaluation of IBI308 in Patients with advanced or metastatic Non-squamous NSCLC

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Sign written informed consent before any trial-related processes are implemented;
✓. Age ≥ 18 years and \<75 years;
✓. Life expectancy exceeds 3 months;
✓. The investigator confirmed at least one measurable lesion according to RECIST 1.1.
✓. According to the International Lung Cancer Research Association and the American Association for the Classification of Cancer Classification, the 8th edition of the TNM (Tumor Node Metastasis) staging of lung cancer, a histologically or cytologically confirmed locally advanced (IIIB/IIIC phase) that cannot be treated surgically and cannot undergo radical concurrent chemoradiotherapy, Patients with metastatic or recurrent (stage IV) non-squamous NSCLC;
✓. Confirmed for patients with EGFR (Epidermal growth factor receptor) or ALK (Anaplastic lymphoma kinase) targeted therapy (documentary evidence of no tumor EGFR-sensitive mutations and no ALK gene rearrangement)
✓. The Eastern Cancer Cooperative Group (ECOG) has a performance score of 0 or 1;
✓. Have not received any systematic anti-tumor treatment for advanced disease; The patient may have received adjuvant chemotherapy as long as the disease relapses at least 6 months after the last dose of chemotherapy is completed;

Exclusion criteria

✕. Histological squamous cell-dominated NSCLC; Mixed cell types must distinguish between dominant cell morphology, and if small cell types are present, the subject is not eligible for inclusion;
✕. Currently participating in interventional clinical research or treatment, or receiving other research drugs or using research equipment within 4 weeks before the first dose;
✕. Previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or against another stimulatory or synergistic inhibition of T cell receptors \[eg CTLA-4 (Cytotoxic T lymphocyte antigen-4), OX-40 (also called CD134, cluster of differentiation134), CD137\] agent;
✕. Received a traditional Chinese medicine with anti-tumor effect, or an immunomodulatory drug (thymosin, interferon, interleukin) within 2 weeks before the first dose, or received major surgery within 3 weeks before the first dose;
✕. Pulmonary radiation therapy of \>30 Gy within 6 months prior to the first dose;
✕. Completed palliative radiotherapy within 7 days prior to the first dose;
✕. Clinical active diverticulitis, abdominal abscess, gastrointestinal obstruction and peritoneal metastasis;
✕. Have received a physical organ or blood system transplant;

What they're measuring

Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Independent Radiographic Review Committee (IRRC)

Timeframe: Trough Database Cutoff Date of 15-Nov-2019 (Up to approximately 16 months)

Trial details

NCT IDNCT03607539

SponsorInnovent Biologics (Suzhou) Co. Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-11-15

Results submitted2020-11-30

View on ClinicalTrials.gov More Lung Neoplasms trials