A Study of Novel Anti-cancer Agents in Patients With Previously Untreated NSCLC (MAGELLAN)

AstraZeneca

Status and phase: Active, not recruiting; Phase 1

Conditions: Metastatic Non-Small Cell Lung Cancer (NSCLC)

Treatments: Drug: AZD2936; Drug: Pemetrexed; Drug: Oleclumab; Drug: Carboplatin; Drug: MEDI5752; Drug: Danvatirsen; Drug: Cisplatin; Drug: Gemcitabine; Drug: Durvalumab; Drug: Nab-paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT03819465

2018-001748-74 (EudraCT Number)

D933IC00001

Details and patient eligibility

About

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)

Full 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).

Enrollment: 175 patients

Sex: All

Ages: 18 to 130 years old

Volunteers: No Healthy Volunteers

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
• Tumors that lack activating EGFR mutations and ALK fusions or documented local test result for any other known genomic alteration for which a targeted therapy is approved in first line per local standard of care
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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175 participants in 10 patient groups

A1

Experimental group

Description:

Durvalumab

Treatment:

Drug: Durvalumab

A2

Experimental group

Description:

Durvalumab + danvatirsen

Treatment:

Drug: Durvalumab

Drug: Danvatirsen

A3

Experimental group

Description:

Durvalumab + oleclumab

Treatment:

Drug: Durvalumab

Drug: Oleclumab

A4

Experimental group

Description:

MEDI5752

Treatment:

Drug: MEDI5752

B1

Experimental group

Description:

Durvalumab + Investigator's choice of chemotherapy

Treatment:

Drug: Nab-paclitaxel

Drug: Durvalumab

Drug: Gemcitabine

Drug: Cisplatin

Drug: Carboplatin

Drug: Pemetrexed

B2

Experimental group

Description:

Durvalumab + Investigator's choice of chemotherapy + danvatirsen

Treatment:

Drug: Nab-paclitaxel

Drug: Durvalumab

Drug: Gemcitabine

Drug: Cisplatin

Drug: Danvatirsen

Drug: Carboplatin

Drug: Pemetrexed

B3

Experimental group

Description:

Durvalumab + investigator's choice of chemotherapy + oleclumab

Treatment:

Drug: Nab-paclitaxel

Drug: Durvalumab

Drug: Gemcitabine

Drug: Cisplatin

Drug: Carboplatin

Drug: Oleclumab

Drug: Pemetrexed

B4

Experimental group

Description:

MEDI5752

Treatment:

Drug: MEDI5752

A5

Experimental group

Description:

AZD2936

Treatment:

Drug: AZD2936

B5

Experimental group

Description:

AZD2936 + chemotherapy

Treatment:

Drug: Cisplatin

Drug: Carboplatin

Drug: AZD2936

Drug: Pemetrexed