Description:
This study is designed to determine the efficacy and safety of durvalumab and/or novel
oncology therapies, with or without chemotherapy, for first-line Stage IV Non-Small Cell Lung
Cancer (NSCLC)
Title
- Brief Title: A Study of Novel Anti-cancer Agents in Patients With Previously Untreated NSCLC
- Official Title: A Phase IB, Open-Label, Multi-Center Study to Determine the Efficacy and Safety of Durvalumab and/or Novel Oncology Therapies, With or Without Chemotherapy, for First-Line Stage IV Non-Small Cell Lung Cancer (NSCLC) (MAGELLAN)
Clinical Trial IDs
- ORG STUDY ID:
D933IC00001
- SECONDARY ID:
2018-001748-74
- NCT ID:
NCT03819465
Conditions
- Metastatic Non-Small Cell Lung Cancer (NSCLC)
Interventions
Drug | Synonyms | Arms |
---|
Durvalumab | MEDI4736 | A1 |
Danvatirsen | AZD9150 | A2 |
Oleclumab | MEDI9447 | A3 |
MEDI5752 | | A4 |
Pemetrexed | | B1 |
Carboplatin | | B1 |
Gemcitabine | | B1 |
Cisplatin | | B1 |
Nab-paclitaxel | | B1 |
Purpose
This study is designed to determine the efficacy and safety of durvalumab and/or novel
oncology therapies, with or without chemotherapy, for first-line Stage IV Non-Small Cell Lung
Cancer (NSCLC)
Detailed Description
This is a Phase IB, Open-Label, Multi-Center Study to Determine the Efficacy and Safety of
Durvalumab and/or Novel Oncology Therapies, With or Without Chemotherapy, for First-Line
Stage IV Non-Small Cell Lung Cancer (NSCLC).
Trial Arms
Name | Type | Description | Interventions |
---|
A1 | Experimental | Durvalumab | |
A2 | Experimental | Durvalumab + danvatirsen | |
A3 | Experimental | Durvalumab + oleclumab | |
A4 | Experimental | MEDI5752 | |
B1 | Experimental | Durvalumab + Investigator's choice of chemotherapy | - Durvalumab
- Pemetrexed
- Carboplatin
- Gemcitabine
- Cisplatin
- Nab-paclitaxel
|
B2 | Experimental | Durvalumab + Investigator's choice of chemotherapy + danvatirsen | - Durvalumab
- Danvatirsen
- Pemetrexed
- Carboplatin
- Gemcitabine
- Cisplatin
- Nab-paclitaxel
|
B3 | Experimental | Durvalumab + investigator's choice of chemotherapy + oleclumab | - Durvalumab
- Oleclumab
- Pemetrexed
- Carboplatin
- Gemcitabine
- Cisplatin
- Nab-paclitaxel
|
B4 | Experimental | MEDI5752 | |
Eligibility Criteria
Inclusion Criteria:
- Histologically or cytologically documented Stage IV NSCLC not amenable to curative
surgery or radiation
- No prior chemotherapy or any other systemic therapy for metastatic NSCLC
- Prior platinum-containing adjuvant, neoadjuvant, or definitive chemoradiation for
advanced disease are eligible, if progression has occurred >12 months from end of last
therapy
- Known tumor PD-L1 status
- WHO/ECOG status at 0 or 1 at enrollment
- Life expectancy of at least 12 weeks
- Troponin I or T ≤ ULN (per institutional guidelines)
Exclusion Criteria:
- Active or prior documented autoimmune or inflammatory disorders
- History of active primary immunodeficiency
- Any prior chemotherapy or any other systemic therapy for metastatic NSCLC
- Untreated CNS metastases
Maximum Eligible Age: | 130 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Assessment of AEs by CTCAE v5.0 |
Time Frame: | From informed consent until the safety follow-up visit 3 months after the last dose of study drug |
Safety Issue: | |
Description: | Assessment of safety and tolerability of each treatment arm |
Secondary Outcome Measures
Measure: | Objective Response Rate (ORR) |
Time Frame: | Approximately 24 months |
Safety Issue: | |
Description: | Assessment of the efficacy of each treatment arm according to RECIST 1.1. ORR: The percentage of evaluable patients with a confirmed Investigator-assessed visit response of CR or PR |
Measure: | Duration of Response (DoR) |
Time Frame: | On-study tumor assessments occur every 6-8 weeks until week 48-52, depending on treatment arm and then every 12 weeks thereafter until confirmed radiological progression, death, withdrawal of consent or study completion, up to approximately 24 months |
Safety Issue: | |
Description: | Assessment of the efficacy of each treatment arm according to RECIST 1.1. DoR: Time from date of first detection of objective response until the date of objective radiological disease progression |
Measure: | Progression Free Survival (PFS) |
Time Frame: | Tumor assessments occur every 6-8 weeks until week 48-52 based on treatment arm & then every 12 weeks until progression, death, withdrawal or study completion up to 24 months. Further PFS data will be collected until 6 months post-last patient dosed |
Safety Issue: | |
Description: | Assessment of the efficacy of each treatment arm according to RECIST 1.1. PFS: Time from date of treatment assignment until the date of objective radiological disease progression using RECIST 1.1 or death (by any cause in the absence of progression) |
Measure: | Overall Survival (OS) |
Time Frame: | Approximately 42 months. Additional OS data will be collected until approximately 6 months post-last patient dosed |
Safety Issue: | |
Description: | OS: Time from date of treatment assignment until the date of death by any cause |
Measure: | Blood concentration of durvalumab and novel oncology therapies |
Time Frame: | From Cycle 1 Day 1 until Cycle 7 Day 1 (each cycle is 28 days) and every 12 weeks thereafter until 3 months following treatment discontinuation |
Safety Issue: | |
Description: | Drug concentration of durvalumab and novel oncology therapies |
Measure: | Frequency of anti-drug antibodies (ADAs) for durvalumab and applicable novel oncology therapies |
Time Frame: | From Cycle 1 Day 1 until Cycle 7 Day 1 (each cycle is 28 days) and every 12 weeks thereafter until 6 months following treatment discontinuation |
Safety Issue: | |
Description: | Investigation of the immunogenicity of durvalumab and each applicable novel oncology therapy in all applicable treatment arms |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | AstraZeneca |
Trial Keywords
- First-Line Stage IV Metastatic Non-Small Cell Lung Cancer
- Stage IV Metastatic Non-Small Cell Lung Cancer
- Metastatic Non-Small Cell Lung Cancer
- Non-Small Cell Lung Cancer
- Non-Small Cell Lung
- Non-Small Cell
- NSCLC
- Non-Small Cell Lung Carcinoma
Last Updated
July 16, 2021