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A Phase II Study of MEDI4736 in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer
EU CTIS ID: 2024-512379-10-00
What this study is testing
Cohort 1: To assess the efficacy of MEDI4736 treatment in terms of ORR in PD-L1 positive patients [abbr. PD-L1+pts] (≥25% of tumour cells with membrane staining [abbr. Tcwmst]). Cohort 2: To assess the efficacy of MEDI4736 treatment in terms of ORR in PD-L1+pts (≥25% of Tcwmst). Cohort 3: To assess the efficacy of MEDI4736 treatment in terms of ORR in PD-L1+pts with ≥90% of Tcwmst.
- Therapeutic exploratory (Phase II)
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
- Provision of signed, written and dated informed consent prior to any study specific procedures
- Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients
- Adequate organ and marrow function
- Male or female aged 18 years or older
- Patients must have EITHER • Histologically- or cytologically-documented NSCLC, OR • Recurrent or progressive disease following multimodal therapy for locally advanced disease
- Patients must have received at least 2 prior systemic treatment regimens for treatment of NSCLC
You likely can't join if
- Participation in another clinical study with an investigational product (IMP) during the last 4 weeks
- Recent major surgery within 4 weeks
- Active or prior documented autoimmune disease within the past 2 years, except for: Vitiligo, Grave's disease, or psoriasis not requiring systemic treatment
- Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis)
- History of primary immunodeficiency
- History of allogeneic organ transplant
See the full eligibility criteria
- Provision of signed, written and dated informed consent prior to any study specific procedures
- Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients
- Adequate organ and marrow function
- Male or female aged 18 years or older
- Patients must have EITHER • Histologically- or cytologically-documented NSCLC, OR • Recurrent or progressive disease following multimodal therapy for locally advanced disease
- Patients must have received at least 2 prior systemic treatment regimens for treatment of NSCLC
- Patients must have experienced disease progression or recurrence after both a platinum-based chemotherapy regimen and at least 1 additional systemic therapy
- Patient's tumour sample must be PD-L1 positive with ≥25% of tumour cells with membrane staining (Cohorts 1 and 2) or PD-L1 positive with ≥ 90% of tumour cells with membrane staining (Cohort 3).
- Patients must have measurable disease
- Life expectancy ≥12 weeks at Day 1
- World Health Organisation (WHO) Performance Status of 0 or 1
- Participation in another clinical study with an investigational product (IMP) during the last 4 weeks
- Recent major surgery within 4 weeks
- Active or prior documented autoimmune disease within the past 2 years, except for: Vitiligo, Grave's disease, or psoriasis not requiring systemic treatment
- Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis)
- History of primary immunodeficiency
- History of allogeneic organ transplant
- History of hypersensitivity to MEDI4736 or any excipient
- Brain metastases or spinal cord compression unless asymptomatic, treated and stable off steroids and anti-convulsants for at least 1 month prior to entry into the study
- Uncontrolled intercurrent illness
- Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving MEDI4736
- History of another primary malignancy except for: • Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of study drug and of low potential risk for recurrence • Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease • Adequately treated carcinoma in situ without evidence of disease eg, cervical cancer in situ.
- Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study
- Female patients who are pregnant or breast-feeding. Male or female patients of reproductive potential who are not using an effective method of birth control
- Any condition that, in the opinion of the investigator, would interfere with evaluation of MEDI4736 or interpretation of patient safety or study results
- Absence of a tumour sample (archival and recent).
- Mixed small cell and NSCLC histology
- Receipt of any immunotherapy, or IMP within 4 weeks prior to the first dose of study drug
- Prior exposure to any anti-PD-1 or anti-PD-L1 antibody
- Any unresolved toxicity CTCAE >Grade 2 from previous anti-cancer therapy
- Any prior Grade ≥3 immune-related adverse event (irAE) while Receiving any previous immunotherapy agent, or any unresolved irAE >Grade 1
- Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment
- Receipt of radiation therapy within 4 weeks prior to starting MEDI4736, or limited field of radiation for palliation within 2 weeks of the first dose of MEDI4736
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- Singapore
- Taiwan
- Japan
- Philippines
- United States
- Thailand
- Canada
- United Kingdom
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 Korea, Republic of; Singapore; Taiwan; Japan; Philippines; United States and 3 more location(s). 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.