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Combination Chemotherapy and Immunotherapy for Non-Small Cell Lung Cancer (NeoCOAST-2 Trial)

Phase 2

Recruiting

Led By Tina Cascone, MD

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

WHO or Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Adequate organ and bone marrow function

Must not have

Active or uncontrolled infections including HBA, HBV, HCV, and HIV

Any concurrent chemotherapy, investigational product, biologic, or hormonal therapy for cancer treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer treatment that uses two drugs, one to attack the cancer and one to boost the immune system. The goal is to see if this treatment is safe and effective.

Who is the study for?

This trial is for newly diagnosed NSCLC patients with resectable disease stages IIA-IIIB, who have good organ and bone marrow function, can provide recent tumor samples to check certain biomarkers, and have a performance status of 0 or 1. It excludes those with autoimmune disorders, prior cancer treatments, planned lung surgeries like pneumonectomy, EGFR mutations/ALK translocations, heart issues including QTcF ≥470 ms, previous immune therapy or specific ADCs use.

What is being tested?

The study tests the safety and effectiveness of perioperative treatment combining Durvalumab with Oleclumab/Monalizumab/AZD0171 plus platinum-based chemo; MEDI5752 plus platinum chemo; or Dato-DXd with Durvalumab and single-agent platinum chemo in early-stage NSCLC that can be surgically removed.

What are the potential side effects?

Potential side effects include reactions related to the immune system affecting organs (like inflammation), infusion-related reactions from the drugs being administered into the bloodstream, fatigue from treatment-induced exhaustion, digestive problems such as nausea or diarrhea due to chemotherapy's effect on rapidly dividing cells including those in the gut lining.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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My organs and bone marrow are working well.

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I have early-stage lung cancer that can be surgically removed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any active or uncontrolled infections.

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I am not currently on any cancer treatments like chemotherapy or hormone therapy.

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I do not have any severe ongoing illnesses that would interfere with the study.

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I have or had an autoimmune or inflammatory disorder.

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I have small-cell lung cancer or a mix of small-cell lung cancer.

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I have no health conditions that prevent me from receiving chemotherapy.

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I have had another type of cancer before.

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I have moderate or severe heart disease.

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My cancer has specific changes in the EGFR gene or ALK gene.

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I have or had lung inflammation treated with steroids, or it's suspected but not confirmed by scans.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2024 Phase 4 trial • 163 Patients • NCT04078152

14%

Intracranial aneurysm

14%

Escherichia infection

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 2: Durvalumab Restart

Cohort 3: No Restart of Durvalumab

Cohort 1: Durvalumab Continuation

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

7Treatment groups

Experimental Treatment

Group I: Arm 7: Dato-DXd + Rilvegostomig + single agent platinumExperimental Treatment4 Interventions

Participants will receive Dato-DXd + Rilvegostomig + single agent platinum as neoadjuvant treatment and Rilvegostomig as adjuvant treatment. Participants will receive one of the following chemotherapy regimens, based on physician choice of as part of their treatment regimen prior to surgery: Carboplatin or Cisplatin

Group II: Arm 6: Rilvegostomig + CTXExperimental Treatment4 Interventions

Participants will receive Rilvegostomig + CTX as neoadjuvant treatment and Rilvegostomig as adjuvant treatment. Participants will receive one of the following chemotherapy regimens, based on the tumour histology and Investigator's discretion, as part of their treatment regimen prior to surgery: Carboplatin/Paclitaxel Pemetrexed/Cisplatin Pemetrexed/Carboplatin

Group III: Arm 5: AZD0171 + durvalumab + CTXExperimental Treatment5 Interventions

Participants will receive AZD0171 + durvalumab + CTX as neoadjuvant treatment and AZD0171 + durvalumab as adjuvant treatment. Participants will receive one of the following chemotherapy regimens, based on the tumour histology and Investigator's discretion, as part of their treatment regimen prior to surgery: Carboplatin/Paclitaxel Pemetrexed/Cisplatin Pemetrexed/Carboplatin

Group IV: Arm 4: Dato-DXd + durvalumab + single agent platinumExperimental Treatment4 Interventions

Participants will receive Dato-DXd + durvalumab + single agent platinum as neoadjuvant treatment and durvalumab as adjuvant treatment. Participants will receive one of the following chemotherapy regimens, based on physician choice of as part of their treatment regimen prior to surgery: Carboplatin or Cisplatin

Group V: Arm 3: Volrustomig (Dose Exploration) + CTXExperimental Treatment4 Interventions

Participants will receive Volrustomig + CTX as neoadjuvant treatment and Volrustomig as adjuvant treatment. Participants will receive one of the following chemotherapy regimens, based on the tumour histology and Investigator's discretion, as part of their treatment regimen prior to surgery: Carboplatin/Paclitaxel Pemetrexed/Cisplatin Pemetrexed/Carboplatin

Group VI: Arm 2: Monalizumab + Durvalumab + CTXExperimental Treatment5 Interventions

Participants will receive Durvalumab + Monalizumab + CTX as neoadjuvant treatment and Durvalumab + Monalizumab as adjuvant treatment. Participants will receive one of the following chemotherapy regimens, based on the tumour histology and Investigator's discretion, as part of their treatment regimen prior to surgery: Carboplatin/Paclitaxel Pemetrexed/Cisplatin Pemetrexed/Carboplatin

Group VII: Arm 1: Oleclumab + Durvalumab + Platinum doublet chemotherapy (CTX)Experimental Treatment5 Interventions

Participants will receive Durvalumab + Oleclumab + CTX as neoadjuvant treatment and Durvalumab + Oleclumab as adjuvant treatment. Participants will receive one of the following chemotherapy regimens, based on the tumour histology and Investigator's discretion, as part of their treatment regimen prior to surgery: Carboplatin/Paclitaxel Pemetrexed/Cisplatin Pemetrexed/Carboplatin

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Oleclumab

2015

Completed Phase 2

~880

Pemetrexed/Carboplatin

2012

Completed Phase 3

~210