Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer (NeoCOAST-2)
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| ClinicalTrials.gov Identifier: NCT05061550 |
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Recruitment Status :
Recruiting
First Posted : September 29, 2021
Last Update Posted : April 17, 2024
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Non-small Cell Lung Cancer | Drug: Durvalumab Drug: Oleclumab Drug: Monalizumab Drug: Dato-DXd Drug: AZD0171 Drug: Carboplatin Drug: Cisplatin Drug: Pemetrexed/Cisplatin Drug: Pemetrexed/Carboplatin Drug: Carboplatin/Paclitaxel Drug: Volrustomig | Phase 2 |
This is an open-label, multi-arms, multicentre, randomised study, eligible participants will be enrolled and randomised to one of the following treatment regimens.
Arm 1: Participants will receive Oleclumab + durvalumab + CTX as neoadjuvant treatment and Oleclumab + durvalumab as adjuvant treatment.
Arm 2: Participants will receive Monalizumab + durvalumab + CTX as neoadjuvant treatment and Monalizumab + durvalumab as adjuvant treatment.
Arm 3: Participants will receive Volrustomig (Dose Exploration) + CTX as neoadjuvant treatment and Volrustomig as adjuvant treatment.
Arm 4: Participants will receive Dato-DXd + durvalumab + single agent platinum chemotherapy as neoadjuvant treatment and durvalumab as adjuvant treatment.
Arm 5: Participants will receive AZD0171 + durvalumab + CTX as neoadjuvant treatment and AZD0171 + durvalumab as adjuvant treatment.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 490 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase II, Open-label, Multicentre, Randomised Study of Neoadjuvant and Adjuvant Treatment in Patients With Resectable, Early-stage (II to IIIB) Non-small Cell Lung Cancer (NeoCOAST-2) |
| Actual Study Start Date : | April 14, 2022 |
| Estimated Primary Completion Date : | December 22, 2028 |
| Estimated Study Completion Date : | December 22, 2028 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Arm 1: Oleclumab + Durvalumab + Platinum doublet chemotherapy (CTX)
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 |
Drug: Durvalumab
Participants will receive Durvalumab via intravenous route.
Other Name: MEDI4736, IMFINZI Drug: Oleclumab Participants will receive Oleclumab via intravenous route.
Other Name: MEDI9447 Drug: Pemetrexed/Cisplatin Pemetrexed/Cisplatin as chemotherapy Drug: Pemetrexed/Carboplatin Pemetrexed/Carboplatin as chemotherapy Drug: Carboplatin/Paclitaxel Carboplatin/Paclitaxel, as chemotherapy |
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Experimental: Arm 2: Monalizumab + Durvalumab + CTX
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 |
Drug: Durvalumab
Participants will receive Durvalumab via intravenous route.
Other Name: MEDI4736, IMFINZI Drug: Monalizumab Participants will receive Monalizumab via intravenous route.
Other Name: IPH2201 Drug: Pemetrexed/Cisplatin Pemetrexed/Cisplatin as chemotherapy Drug: Pemetrexed/Carboplatin Pemetrexed/Carboplatin as chemotherapy Drug: Carboplatin/Paclitaxel Carboplatin/Paclitaxel, as chemotherapy |
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Experimental: Arm 3: Volrustomig (Dose Exploration) + CTX
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 |
Drug: Pemetrexed/Cisplatin
Pemetrexed/Cisplatin as chemotherapy Drug: Pemetrexed/Carboplatin Pemetrexed/Carboplatin as chemotherapy Drug: Carboplatin/Paclitaxel Carboplatin/Paclitaxel, as chemotherapy Drug: Volrustomig Participants will receive Volrustomig via intravenous route.
Other Name: MEDI5752 |
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Experimental: Arm 4: Dato-DXd + durvalumab + single agent platinum
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 |
Drug: Durvalumab
Participants will receive Durvalumab via intravenous route.
Other Name: MEDI4736, IMFINZI Drug: Dato-DXd Participants will receive datopotamab deruxtecan (Dato-DXd) via intravenous route. Drug: Carboplatin Carboplatin as chemotherapy Drug: Cisplatin Cisplatin as chemotherapy |
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Experimental: Arm 5: AZD0171 + durvalumab + CTX
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 |
Drug: Durvalumab
Participants will receive Durvalumab via intravenous route.
Other Name: MEDI4736, IMFINZI Drug: AZD0171 Participants will receive AZD0171 via intravenous route. Drug: Pemetrexed/Cisplatin Pemetrexed/Cisplatin as chemotherapy Drug: Pemetrexed/Carboplatin Pemetrexed/Carboplatin as chemotherapy Drug: Carboplatin/Paclitaxel Carboplatin/Paclitaxel, as chemotherapy |
- Number of participants with pathological complete response (pCR) [ Time Frame: From randomization to approximately 15 weeks after the first dose of study interventions ]
- Number of participants with adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: Until Day 90 after the last dose of study interventions (Up to approximately 3 years) ]
- Number of participants experiencing an event-free survival (EFS) event [ Time Frame: Up to approximately 3 years ]
- Number of participants experiencing a disease-free survival (DFS) event [ Time Frame: Up to approximately 3 years ]
- Number of participants having surgical resection [ Time Frame: From randomization to approximately 15 weeks after the first dose of study interventions ]
- Number of participants with major pathological response (mPR) [ Time Frame: From randomization to approximately 15 weeks after the first dose of study interventions ]
- Number of participants with Objective response rate (ORR) [ Time Frame: From randomization to approximately 15 weeks after the first dose of study interventions ]
- Overall survival (OS) [ Time Frame: Up to approximately 3 years ]
- Serum concentration of study interventions (Durvalumab/Oleclumab/Monalizumab/Volrustomig) [ Time Frame: From randomization to last dose of study interventions (Up to approximately 3 Years) ]
- Number of participants with anti-study drug antibodies (ADA) [ Time Frame: From randomization to 3 months after last dose of study interventions (Up to approximately 3 Years) ]
- Baseline PD-L1 expression [ Time Frame: At Screening/ baseline ]
- Changes in circulating tumour DNA (ctDNA) [ Time Frame: From randomization to up to 24 months after last dose of study interventions (Up to approximately 3 Years) ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 95 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Newly diagnosed NSCLC patients with resectable disease (Stage IIA to Stage IIIB).
- WHO or Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ and bone marrow function.
- Provision of tumour samples (newly acquired or archival tumour tissue [≤ 6 months old]) to confirm Programmed death-ligand 1 (PD-L1) status, epidermal growth factor receptor (EGFR), or anaplastic lymphoma kinase (ALK) status.
- Adequate pulmonary function.
Exclusion Criteria:
- Participants with sensitising EGFR mutations or ALK translocations.
- Active or prior documented autoimmune or inflammatory disorders.
- Uncontrolled intercurrent illness, uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active bleeding diseases, serious chronic gastrointestinal conditions associated with diarrhoea, or psychiatric illness/social situations that would limit compliance with study requirement.
- History of another primary malignancy.
- Participants with small-cell lung cancer or mixed small-cell lung cancer.
- History of active primary immunodeficiency.
- History of non-infectious ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
- Participants who have preoperative radiotherapy treatment as part of their care plan.
- Participants who require or may require pneumonectomy, segmentectomies, or wedge resections, as assessed by their surgeon at baseline, to obtain potentially curative resection of primary tumour.
- QTcF (QT interval corrected by Fridericia's formula) interval ≥ 470 ms.
- Any medical contraindication to treatment with chemotherapy as listed in the local labelling.
- Participants with moderate or severe cardiovascular disease.
- Any concurrent chemotherapy, investigational product, biologic, or hormonal therapy for cancer treatment.
- Receipt of live attenuated vaccine within 30 days prior to the first dose of study interventions.
- Prior exposure to approved or investigational immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies. Participants who received agents targeting the adenosine pathway, anti-NKG2A, anti-HLA-E agents, and anti-LIF agents are also excluded. Participants who have received previous treatment with a TROP2 targeting ADC or with another ADC containing a chemotherapy agent that inhibits TOP1 activity are also excluded.
- Current or prior use of immunosuppressive medication within 14 days before the first dose of study interventions.
- Active or uncontrolled infections including HBA, HBV, HCV, and HIV.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05061550
| Contact: AstraZeneca Clinical Study Information Center | 1-877-240-9479 | information.center@astrazeneca.com |
Show 96 study locations
| Principal Investigator: | Tina Cascone, MD | MD Anderson Cancer Center Houston, TX 77030 |
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT05061550 |
| Other Study ID Numbers: |
D9077C00001 2023-508852-21-00 ( Other Identifier: EU CT Number ) 2021-003369-37 ( EudraCT Number ) |
| First Posted: | September 29, 2021 Key Record Dates |
| Last Update Posted: | April 17, 2024 |
| Last Verified: | April 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) |
| Time Frame: | AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. |
| Access Criteria: | When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. |
| URL: | https://vivli.org/ |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Lung Cancer early-stage Durvalumab Oleclumab Monalizumab AZD0171 |
Datopotamab Deruxtecan Neoadjuvant Adjuvant Chemotherapy Volrustomig |
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Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Paclitaxel Cisplatin Carboplatin |
Pemetrexed Durvalumab Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors Antineoplastic Agents, Immunological |