BridgeMD
Effect of study drug combined with chemotherapy in patients with locally advanced or metastatic lung cancer with mutated receptor responsible for epithelial growth (EGF-R) that progressed after the treatment with other drugs.
EU CTIS ID: 2023-504434-22-00
What this study is testing
1) To compare overall survival (OS) in the Modified Intent-to-Treat (mITT) population between AK112 combined with pemetrexed and carboplatin and placebo combined with pemetrexed and carboplatin, in patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations who have progressed on or following EGFR tyrosine kinase inhibitor (TKI) therapy. 2) To compare progression-free survival (PFS) assessed by the Independent Radiology Review Committee (IRRC) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, in the mITT population between AK112 combined with pemetrexed and carboplatin and placebo combined with pemetrexed and carboplatin, in patients with locally advanced or metastatic non-squamous NSCLC with EGFR mutations who have progressed on or following EGFR TKI therapy.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
- Life expectancy ≥ 3 months
- Locally advanced (stage IIIB/IIIC) or metastatic (stage IV) non-squamous NSCLC confirmed by histology or cytology, inoperable and unable to receive radiotherapy and chemotherapy
- The tumor histology, cytology or blood test confirmed the presence of EGFR activating mutations before enrollment
- Have previously received EGFR-TKI treatment and the treatment has failed
- Subjects have at least one measurable non-brain tumor lesion per RECIST v1.1
You likely can't join if
- Histological or cytological pathology confirmed the presence of small cell carcinoma components, or the main component is squamous cell carcinoma
- Active autoimmune disease requiring systemic treatment within 2 years prior to the start of study treatment
- There is a history of major diseases 1 year prior to the first dose
- Medical history of gastrointestinal perforation or gastrointestinal fistula within 6 months prior to the first dose
- Received chest radiation therapy prior to the first dose
- Presence of clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring frequent drainage
See the full eligibility criteria
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
- Life expectancy ≥ 3 months
- Locally advanced (stage IIIB/IIIC) or metastatic (stage IV) non-squamous NSCLC confirmed by histology or cytology, inoperable and unable to receive radiotherapy and chemotherapy
- The tumor histology, cytology or blood test confirmed the presence of EGFR activating mutations before enrollment
- Have previously received EGFR-TKI treatment and the treatment has failed
- Subjects have at least one measurable non-brain tumor lesion per RECIST v1.1
- Major organ function prior to treatment meets the criteria defined in Protocol
- Patients of childbearing potential must agree to use highly effective contraceptive measures
- Histological or cytological pathology confirmed the presence of small cell carcinoma components, or the main component is squamous cell carcinoma
- Active autoimmune disease requiring systemic treatment within 2 years prior to the start of study treatment
- There is a history of major diseases 1 year prior to the first dose
- Medical history of gastrointestinal perforation or gastrointestinal fistula within 6 months prior to the first dose
- Received chest radiation therapy prior to the first dose
- Presence of clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring frequent drainage
- Active or previously documented inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis)
- There are reports confirming the existence of other driver gene mutations with known drug treatments
- Subjects who received any prior treatments targeting the mechanism of tumor immunity
- The subject has received systemic anti-tumor therapy other than EGFR-TKI
- Currently enrolled in any other clinical study
- Received EGFR-TKI treatment, palliative local treatment, non-specific immunomodulatory treatment within 2 weeks prior to the first dose; and Chinese herbal medicine or traditional Chinese medicinal products with anti-tumor indications within 1 weeks prior to the first dose
- Tumor surrounds important blood vessels or has obvious necrosis, cavitation, or invades surrounding important organs and blood vessels
- Symptomatic central nervous system metastases
- Active malignancies within the past 3 years, with the exception of tumors in this study and cured local tumors
The study team makes the final eligibility decision.
Where it's taking place
- United States
- United Kingdom
- Canada
- China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; United Kingdom; Canada; China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.