Description:
Study D9108C00002 (NeoCOAST) is a platform study assessing the effectiveness and safety of
neoadjuvant durvalumab alone or in combination with novel agents in subjects with resectable,
early-stage (Stage I [>2cm] to IIIA) non-small cell lung cancer (NSCLC).
Title
- Brief Title: Neoadjuvant Durvalumab Alone or in Combination With Novel Agents in Resectable Non-Small Cell Lung Cancer
- Official 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)
Clinical Trial IDs
- ORG STUDY ID:
D9108C00002
- NCT ID:
NCT03794544
Conditions
- Resectable
- Early-stage
- NSCLC
Interventions
Drug | Synonyms | Arms |
---|
Durvalumab | | Arm A: Durvalumab monotherapy |
Purpose
Study D9108C00002 (NeoCOAST) is a platform study assessing the effectiveness and safety of
neoadjuvant durvalumab alone or in combination with novel agents in subjects with resectable,
early-stage (Stage I [>2cm] to IIIA) non-small cell lung cancer (NSCLC).
Trial Arms
Name | Type | Description | Interventions |
---|
Arm A: Durvalumab monotherapy | Experimental | durvalumab IV | |
Arm B: Durvalumab + Oleclumab | Experimental | durvalumab IV and oleclumab IV | |
Arm C: Durvalumab + Monalizumab | Experimental | durvalumab IV and monalizumab IV | |
Arm D: Durvalumab + Danvatirsen | Experimental | danvatirsen IV and durvalumab IV | |
Eligibility Criteria
Inclusion Criteria:
1. Cytologically and/or histologically-documented NSCLC
1. Stage I (> 2 cm) to IIIA (for subjects 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
2. Amenable to complete surgical resection
3. Have not received any other therapy for this condition
2. Age ≥18 years old
3. Predicted FEV1 ≥ 50%
4. Predicted DLCO ≥ 50%
5. ECOG 0 or 1
6. Adequate organ function
Exclusion Criteria:
1. Subjects with small-cell lung cancer or mixed small-cell lung cancer
2. Subjects who require or may require pneumonectomy
3. Prior treatment with PD-L1, PD-L1, or CTLA-4 inhibitors
4. Current or prior use of immunosuppressive medication within 14 days before the first
dose of study drug.
5. Active or prior documented autoimmune or inflammatory disorders. The following are
exceptions to this criterion:
1. Subjects with vitiligo or alopecia
2. Subjects with hypothyroidism on hormone replacement
3. Any chronic skin condition that does not require systemic therapy
4. Subjects without active disease in the last 5 years may be included but only
after consultation with the study physician
5. Subjects with celiac disease controlled by diet alone
6. Pregnant or breast-feeding female
7. Major surgical procedure within prior 30 days
8. History of active primary immunodeficiency
9. Active infection including tuberculosis, hepatitis B, hepatitis C, or HIV
10. QTc interval (QTc) ≥ 470 ms
11. Uncontrolled intercurrent illness that would limit compliance with study requirement,
substantially increase risk of incurring AEs or compromise the ability of the subject
to give written informed consent
12. Receipt of live attenuated vaccination within 30 days prior to study entry
13. History of another primary malignancy except for:
1. Curative-treated malignancy with no known active disease > 2 years before
enrollment on the study
2. Curative-treated non-melanoma skin cancer and/or carcinoma in-situ
Maximum Eligible Age: | 102 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Major Pathological Response rate |
Time Frame: | Major Pathological Response will be done in the resected specimen. Surgery is planned to take place within 14 days after the 4 weeks treatment period. |
Safety Issue: | |
Description: | Assess the antitumor activity of durvalumab alone and/or in combination with novel agents |
Secondary Outcome Measures
Measure: | Feasibility to surgery within the 14 days window period is a dichotomic variable: patients will have or will not have the tumor surgical resection done. |
Time Frame: | Surgery is planned to take place within 14 days after the 4 weeks treatment period. |
Safety Issue: | |
Description: | Assess the feasibility of receiving the planned surgical resection |
Measure: | AEs and SAEs |
Time Frame: | Up to 126 days after C1D1 |
Safety Issue: | |
Description: | Assess the safety and tolerability of durvalumab alone and/or in combination with novel agents |
Measure: | Pathological Complete Response rate |
Time Frame: | Pathological Complete Response will be done in the resected specimen. Surgery is planned to take place within 14 days after the 4 weeks treatment period. |
Safety Issue: | |
Description: | Assess the antitumor activity of durvalumab alone and/or in combination with novel agents |
Measure: | Concentration of durvalumab or novel agents in plasma or serum. |
Time Frame: | Up to 126 days after C1D1 |
Safety Issue: | |
Description: | To describe the PK of durvalumab alone and/or in combination with novel agents |
Measure: | ADA incidence of durvalumab or novel biologic agents. |
Time Frame: | Up to 126 days after C1D1 |
Safety Issue: | |
Description: | To assess the immunogenicity of durvalumab alone or in combination with novel agents
To assess the immunogenicity of novel biologic agents in combination with durvalumab |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Completed |
Lead Sponsor: | MedImmune LLC |
Trial Keywords
- Neoadjuvant
- Non-small Cell Lung Cancer
- Cancer
- Lung
- Resectable
- Early-stage
- Stage I
- Stage II
- Stage IIIA
- Durvalumab
Last Updated
May 28, 2021