Phase 2
Completed N=84
Neoadjuvant Durvalumab Alone or in Combination With Novel Agents in Resectable Non-Small Cell Lung Cancer
Resectable · Early-stage · NSCLC
Source: ClinicalTrials.gov NCT03794544 ↗
Enrolled (actual)
84
Serious AEs
13.3%
Results posted
Feb 2022
Primary outcomePrimary: Major Pathological Response Rate — 11.1; 19.0; 30.0; 31.3 Percentage of participants
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Major Pathological Response Rate |
11.1; 19.0; 30.0; 31.3 | — |
| SECONDARY Pathological Complete Response (pCR) Rate |
3.7; 9.5; 10.0; 12.5 | — |
| SECONDARY Feasibility to Surgery |
84.6; 81.0; 90.0; 93.8 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) |
18; 19; 15; 13; 3; 2 | — |
| SECONDARY Number of Participants With Grade 3 or Grade 4 Clinical Laboratory Toxicities |
0; 0; 0; 2; 0; 0 | — |
| SECONDARY Number of Participants With Abnormal Vital Signs Reported as TEAEs |
1; 0; 0; 0; 1; 2 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03794544). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.