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

NCT ID: NCT03819465

Last Updated: 2025-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-27

Study Completion Date

2026-03-26

Brief Summary

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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)

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Detailed Description

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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).

Conditions

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Metastatic Non-Small Cell Lung Cancer (NSCLC)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Treatment arms for MEDI5752 (Arms A4 and B4) will enroll 42 and 60 patients, respectively. Arm B5 (AZD2936+chemotherapy) will enroll 60 patients.

For all other treatment arms, 30 patients will be enrolled into each arm; additional patients may be enrolled in order to have 30 evaluable patients per arm (ie, dosed).
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A1

Durvalumab

Group Type EXPERIMENTAL

Durvalumab

Intervention Type DRUG

Durvalumab IV Cohort A: Every 4 weeks (q4w) Cohort B: Every 3 weeks (q3w) for the first 4 cycles, then every 4 weeks (q4w) starting at Cycle 5 Day 1

A2

Durvalumab + danvatirsen

Group Type EXPERIMENTAL

Durvalumab

Intervention Type DRUG

Durvalumab IV Cohort A: Every 4 weeks (q4w) Cohort B: Every 3 weeks (q3w) for the first 4 cycles, then every 4 weeks (q4w) starting at Cycle 5 Day 1

Danvatirsen

Intervention Type DRUG

Danvatirsen IV Loading dose Cycle 1 Day 1, Cycle 1 Day 3, and Cycle 1 Day 5 then once a week (q1w) starting at Cycle 1 Day 8

A3

Durvalumab + oleclumab

Group Type EXPERIMENTAL

Durvalumab

Intervention Type DRUG

Durvalumab IV Cohort A: Every 4 weeks (q4w) Cohort B: Every 3 weeks (q3w) for the first 4 cycles, then every 4 weeks (q4w) starting at Cycle 5 Day 1

Oleclumab

Intervention Type DRUG

Oleclumab IV Cohort A: Every 2 weeks (q2w) for first 2 cycles, then every 4 weeks (q4w) starting at Cycle 3 Day 1 Cohort B: Every 3 weeks (q3w) for the first 4 cycles, then every 4 weeks (q4w) starting at Cycle 5 Day 1

A4

MEDI5752

Group Type EXPERIMENTAL

MEDI5752

Intervention Type DRUG

MEDI5752 IV Every 3 weeks (q3w)

B1

Durvalumab + Investigator's choice of chemotherapy

Group Type EXPERIMENTAL

Durvalumab

Intervention Type DRUG

Durvalumab IV Cohort A: Every 4 weeks (q4w) Cohort B: Every 3 weeks (q3w) for the first 4 cycles, then every 4 weeks (q4w) starting at Cycle 5 Day 1

Pemetrexed

Intervention Type DRUG

Pemetrexed IV Day 1 of each 21-day cycle Arm B1: Day 1 of each 21-day cycle for the first 4 cycles then either every 3 weeks (q3w) or every 4 weeks (q4w) (per investigator discretion) thereafter Arm B2 and B3: Day 1 of each 21-day cycle for the first 4 cycles then Day 1 of each 28-day cycle (q4w) thereafter Arm B5: Day 1 of each 21-day cycle throughout the study

Carboplatin

Intervention Type DRUG

Carboplatin IV Day 1 of each 21-day cycle

Gemcitabine

Intervention Type DRUG

Gemcitabine IV Days 1 and 8 of each 21-day cycle

Cisplatin

Intervention Type DRUG

Cisplatin IV Day 1 of each 21-day cycle

Nab-paclitaxel

Intervention Type DRUG

Nab-paclitaxel IV Days 1, 8, and 15 of each 21-day cycle

B2

Durvalumab + Investigator's choice of chemotherapy + danvatirsen

Group Type EXPERIMENTAL

Durvalumab

Intervention Type DRUG

Durvalumab IV Cohort A: Every 4 weeks (q4w) Cohort B: Every 3 weeks (q3w) for the first 4 cycles, then every 4 weeks (q4w) starting at Cycle 5 Day 1

Danvatirsen

Intervention Type DRUG

Danvatirsen IV Loading dose Cycle 1 Day 1, Cycle 1 Day 3, and Cycle 1 Day 5 then once a week (q1w) starting at Cycle 1 Day 8

Pemetrexed

Intervention Type DRUG

Pemetrexed IV Day 1 of each 21-day cycle Arm B1: Day 1 of each 21-day cycle for the first 4 cycles then either every 3 weeks (q3w) or every 4 weeks (q4w) (per investigator discretion) thereafter Arm B2 and B3: Day 1 of each 21-day cycle for the first 4 cycles then Day 1 of each 28-day cycle (q4w) thereafter Arm B5: Day 1 of each 21-day cycle throughout the study

Carboplatin

Intervention Type DRUG

Carboplatin IV Day 1 of each 21-day cycle

Gemcitabine

Intervention Type DRUG

Gemcitabine IV Days 1 and 8 of each 21-day cycle

Cisplatin

Intervention Type DRUG

Cisplatin IV Day 1 of each 21-day cycle

Nab-paclitaxel

Intervention Type DRUG

Nab-paclitaxel IV Days 1, 8, and 15 of each 21-day cycle

B3

Durvalumab + investigator's choice of chemotherapy + oleclumab

Group Type EXPERIMENTAL

Durvalumab

Intervention Type DRUG

Durvalumab IV Cohort A: Every 4 weeks (q4w) Cohort B: Every 3 weeks (q3w) for the first 4 cycles, then every 4 weeks (q4w) starting at Cycle 5 Day 1

Oleclumab

Intervention Type DRUG

Oleclumab IV Cohort A: Every 2 weeks (q2w) for first 2 cycles, then every 4 weeks (q4w) starting at Cycle 3 Day 1 Cohort B: Every 3 weeks (q3w) for the first 4 cycles, then every 4 weeks (q4w) starting at Cycle 5 Day 1

Pemetrexed

Intervention Type DRUG

Pemetrexed IV Day 1 of each 21-day cycle Arm B1: Day 1 of each 21-day cycle for the first 4 cycles then either every 3 weeks (q3w) or every 4 weeks (q4w) (per investigator discretion) thereafter Arm B2 and B3: Day 1 of each 21-day cycle for the first 4 cycles then Day 1 of each 28-day cycle (q4w) thereafter Arm B5: Day 1 of each 21-day cycle throughout the study

Carboplatin

Intervention Type DRUG

Carboplatin IV Day 1 of each 21-day cycle

Gemcitabine

Intervention Type DRUG

Gemcitabine IV Days 1 and 8 of each 21-day cycle

Cisplatin

Intervention Type DRUG

Cisplatin IV Day 1 of each 21-day cycle

Nab-paclitaxel

Intervention Type DRUG

Nab-paclitaxel IV Days 1, 8, and 15 of each 21-day cycle

B4

MEDI5752

Group Type EXPERIMENTAL

MEDI5752

Intervention Type DRUG

MEDI5752 IV Every 3 weeks (q3w)

A5

AZD2936

Group Type EXPERIMENTAL

AZD2936

Intervention Type DRUG

AZD2936 IV

B5

AZD2936 + chemotherapy

Group Type EXPERIMENTAL

Pemetrexed

Intervention Type DRUG

Pemetrexed IV Day 1 of each 21-day cycle Arm B1: Day 1 of each 21-day cycle for the first 4 cycles then either every 3 weeks (q3w) or every 4 weeks (q4w) (per investigator discretion) thereafter Arm B2 and B3: Day 1 of each 21-day cycle for the first 4 cycles then Day 1 of each 28-day cycle (q4w) thereafter Arm B5: Day 1 of each 21-day cycle throughout the study

Carboplatin

Intervention Type DRUG

Carboplatin IV Day 1 of each 21-day cycle

Cisplatin

Intervention Type DRUG

Cisplatin IV Day 1 of each 21-day cycle

AZD2936

Intervention Type DRUG

AZD2936 IV

Interventions

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Durvalumab

Durvalumab IV Cohort A: Every 4 weeks (q4w) Cohort B: Every 3 weeks (q3w) for the first 4 cycles, then every 4 weeks (q4w) starting at Cycle 5 Day 1

Intervention Type DRUG

Danvatirsen

Danvatirsen IV Loading dose Cycle 1 Day 1, Cycle 1 Day 3, and Cycle 1 Day 5 then once a week (q1w) starting at Cycle 1 Day 8

Intervention Type DRUG

Oleclumab

Oleclumab IV Cohort A: Every 2 weeks (q2w) for first 2 cycles, then every 4 weeks (q4w) starting at Cycle 3 Day 1 Cohort B: Every 3 weeks (q3w) for the first 4 cycles, then every 4 weeks (q4w) starting at Cycle 5 Day 1

Intervention Type DRUG

MEDI5752

MEDI5752 IV Every 3 weeks (q3w)

Intervention Type DRUG

Pemetrexed

Pemetrexed IV Day 1 of each 21-day cycle Arm B1: Day 1 of each 21-day cycle for the first 4 cycles then either every 3 weeks (q3w) or every 4 weeks (q4w) (per investigator discretion) thereafter Arm B2 and B3: Day 1 of each 21-day cycle for the first 4 cycles then Day 1 of each 28-day cycle (q4w) thereafter Arm B5: Day 1 of each 21-day cycle throughout the study

Intervention Type DRUG

Carboplatin

Carboplatin IV Day 1 of each 21-day cycle

Intervention Type DRUG

Gemcitabine

Gemcitabine IV Days 1 and 8 of each 21-day cycle

Intervention Type DRUG

Cisplatin

Cisplatin IV Day 1 of each 21-day cycle

Intervention Type DRUG

Nab-paclitaxel

Nab-paclitaxel IV Days 1, 8, and 15 of each 21-day cycle

Intervention Type DRUG

AZD2936

AZD2936 IV

Intervention Type DRUG

Other Intervention Names

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MEDI4736 AZD9150 MEDI9447

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

130 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sandip Patel, MD

Role: PRINCIPAL_INVESTIGATOR

UCSD Morres Cancer Center

Chih-Hsin Yang, MD

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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Research Site

Iowa City, Iowa, United States

Site Status

Research Site

Pittsburgh, Pennsylvania, United States

Site Status

Research Site

Nashville, Tennessee, United States

Site Status

Research Site

Salzburg, , Austria

Site Status

Research Site

Vienna, , Austria

Site Status

Research Site

Edegem, , Belgium

Site Status

Research Site

Bialystok, , Poland

Site Status

Research Site

Bydgoszcz, , Poland

Site Status

Research Site

Gdansk, , Poland

Site Status

Research Site

Grudziądz, , Poland

Site Status

Research Site

Lodz, , Poland

Site Status

Research Site

Olsztyn, , Poland

Site Status

Research Site

Tomaszów Mazowiecki, , Poland

Site Status

Research Site

Warsaw, , Poland

Site Status

Research Site

Wroclaw, , Poland

Site Status

Research Site

Krasnoyarsk, , Russia

Site Status

Research Site

Moscow, , Russia

Site Status

Research Site

Saint Petersburg, , Russia

Site Status

Research Site

Saint Petersburg, , Russia

Site Status

Research Site

Cheongju-si, , South Korea

Site Status

Research Site

Seoul, , South Korea

Site Status

Research Site

Seoul, , South Korea

Site Status

Research Site

Seoul, , South Korea

Site Status

Research Site

Seoul, , South Korea

Site Status

Research Site

Barcelona, , Spain

Site Status

Research Site

Barcelona, , Spain

Site Status

Research Site

Madrid, , Spain

Site Status

Research Site

Madrid, , Spain

Site Status

Research Site

Seville, , Spain

Site Status

Research Site

Kaohsiung City, , Taiwan

Site Status

Research Site

Taichung, , Taiwan

Site Status

Research Site

Taichung, , Taiwan

Site Status

Research Site

Tainan City, , Taiwan

Site Status

Research Site

Taipei, , Taiwan

Site Status

Research Site

Taipei, , Taiwan

Site Status

Research Site

Taipei, , Taiwan

Site Status

Research Site

Taoyuan District, , Taiwan

Site Status

Research Site

Bangkok, , Thailand

Site Status

Research Site

Bangkok, , Thailand

Site Status

Research Site

Chiang Mai, , Thailand

Site Status

Research Site

Hat Yai, , Thailand

Site Status

Countries

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United States Austria Belgium Poland Russia South Korea Spain Taiwan Thailand

Other Identifiers

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2018-001748-74

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

D933IC00001

Identifier Type: -

Identifier Source: org_study_id

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