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NCT Number: NCT03794544

Neoadjuvant Durvalumab Alone or in Combination With Novel Agents in Resectable Non-Small Cell Lung Cancer

Study D9108C00002 (NeoCOAST) is a platform study assessing the effectiveness and safety of neoadjuvant durvalumab alone or in combination with novel agents in participants with resectable, early-stage (Stage I [>2cm] to IIIA) non-small cell lung cancer (NSCLC).

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Key information

Conditions

Resectable Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Early-stage Lung Diseases Lung Neoplasms NSCLC Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–102 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Montreal, Quebec, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Cytologically and/or histologically-documented NSCLC
  • Stage I (> 2 cm) to IIIA (for participants with N2 disease, only those with 1 single nodal station ≤ 3 cm are eligible) NSCLC according to the 8th edition of American Joint Committee on Cancer staging classification
  • Amenable to complete surgical resection
  • Have not received any other therapy for this condition
  • Predicted forced expiratory volume in one second (FEV1) ≥ 50%
  • Predicted diffusing capacity of the lungs for carbon monoxide (DLCO) ≥ 50%
  • ECOG 0 or 1
  • Adequate organ function

Exclusion criteria

  • Participants with small-cell lung cancer or mixed small-cell lung cancer
  • Participants who require or may require pneumonectomy
  • Prior treatment with programmed cell death ligand-1 (PD-L1), PD-L1, or cytotoxic T-lymphocyte antigen 4 (CTLA-4) inhibitors
  • Current or prior use of immunosuppressive medication within 14 days before the first dose of study drug.
  • Active or prior documented autoimmune or inflammatory disorders. The following are exceptions to this criterion:
  • Participants with vitiligo or alopecia
  • Participants with hypothyroidism on hormone replacement
  • Any chronic skin condition that does not require systemic therapy
  • Participants without active disease in the last 5 years may be included but only after consultation with the study physician
  • Participants with celiac disease controlled by diet alone
  • Pregnant or breast-feeding female
  • Major surgical procedure within prior 30 days
  • History of active primary immunodeficiency
  • Active infection including tuberculosis, hepatitis B, hepatitis C, or HIV
  • QTc interval (QTc) ≥ 470 ms
  • Uncontrolled intercurrent illness that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the participant to give written informed consent
  • Receipt of live attenuated vaccination within 30 days prior to study entry
  • History of another primary malignancy except for:
  • Curative-treated malignancy with no known active disease > 2 years before enrollment on the study
  • Curative-treated non-melanoma skin cancer and/or carcinoma in-situ

Treatment and study plan

Durvalumab

Drug

Durvalumab 1500 mg IV will be administered Q4W (on Week 1 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period.

Other names: MEDI4736

Oleclumab

Combination Product

Oleclumab 3000 mg IV will be administered Q2W (on Week 1 Day 1 and Week 3 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period.

Other names: MEDI9447

Monalizumab

Combination Product

Monalizumab 750 mg IV will be administered Q2W (on Week 1 Day 1 and Week 3 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period.

Other names: IPH2201

Danvatirsen

Combination Product

Danvatirsen 200 mg IV will be administered on Days 1, 3, and 5 of Week 0 (7-day danvatirsen lead-in period) and later every week (on Week 1 Day 1, Week 2 Day 1, Week 3 Day 1, and Week 4 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period.

Other names: AZD9150

Primary outcomes

  1. Major Pathological Response Rate

    Time frame: Day 1 through Day 42

    Major pathological response rate is defined as percentage of participants with <=10% residual viable tumor cells in the resected specimen.

Secondary outcomes

  1. Pathological Complete Response (pCR) Rate

    Time frame: Day 1 through Day 42

    The pCR rate is defined as percentage of participants with no residual viable tumor cells in the resected specimen.

  2. Feasibility to Surgery

    Time frame: Day 29 to Day 42 after Week 1 Day 1

    Feasibility to surgery is defined as the percentage of participants who underwent the planned surgery within Days 29 to 42 after Week 1 Day 1.

  3. Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

    Time frame: From Day 1 through Day 105

    An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug.

  4. Number of Participants With Grade 3 or Grade 4 Clinical Laboratory Toxicities

    Time frame: From Day 1 through Day 105

    Participants with Grade 3 or Grade 4 clinical laboratory toxicities are reported. Laboratory tests included hematology, coagulation, chemistry, and urinalysis.

  5. Number of Participants With Abnormal Vital Signs Reported as TEAEs

    Time frame: From Day 1 through Day 105

    Participants with abnormal vital sign reported as TEAEs are reported.

Sponsors and collaborators

Lead sponsor

MedImmune LLC

Industry

Registry information

Official study title

A Phase 2 Open-label, Multicenter, Randomized, Multidrug Platform Study of Neoadjuvant Durvalumab Alone or in Combination With Novel Agents in Subjects With Resectable, Early-stage (I [> 2 cm] to IIIA) Non-small Cell Lung Cancer (NeoCOAST)

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jan 7, 2019
Registry last updated
Feb 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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