Trial Outcomes & Findings for Durvalumab Followed by Chemoradiation and Consolidation Durvalumab for Stage III Non-small Cell Lung Cancer (NCT NCT04364048)
NCT ID: NCT04364048
Last Updated: 2024-12-20
Results Overview
12-month progression-free survival will be measured using imaging after completion of chemoradiation, prior to C1 consolidation durvalumab (1-42 days after completion of chemoradiation) per RECIST 1.1. RECIST 1.1 Criteria for Response are: Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
From the time of treatment initiation until progression, up to 12 months
Results posted on
2024-12-20
Participant Flow
Participant milestones
| Measure |
Induction Durvalumab, Chemoradiation, Consolidation Durvalumab
Induction durvalumab at 1500 mg intravenously (IV) on Day 1 of a four week cycle for 1 cycle, followed by concurrent definitive chemoradiation, followed by consolidation durvalumab at 1500 mg IV Day 1 of every 4 week cycle for up to 12 cycles.
Induction Durvalumab: Induction durvalumab at 1500 mg intravenously (IV) will be given on Day 1 of a four week cycle for 1 cycle,
Chemotherapy: Concurrent chemoradiation will be with platinum-based chemotherapy (cisplatin or carboplatin, with etoposide, taxane, or pemetrexed) selected at the treating physician's discretion. The chemotherapy regimen used should be administered per institutional standards following the prescribing guidelines for each drug
Radiation: Treatment will be delivered using IMRT or 3DCRT using typically 6-10MV photons per institutional standards. 4D simulation and appropriate IGRT are encouraged. Radiation therapy must begin within one week of the first day of chemotherapy (or vice versa). Therapy will be 1.8-2 Gy per day; 5 days per week, excluding holidays per institutional standard as this is a standard of care regimen for this patient population. 54-66 Gy will be delivered.
Consolidation durvalumab: Durvalumab at 1500 mg intravenously (IV) will be given on Day 1 of a four week cycle for 12 cycles
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Durvalumab Followed by Chemoradiation and Consolidation Durvalumab for Stage III Non-small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Induction Durvalumab, Chemoradiation, Consolidation Durvalumab
n=10 Participants
Induction durvalumab at 1500 mg intravenously (IV) on Day 1 of a four week cycle for 1 cycle, followed by concurrent definitive chemoradiation, followed by consolidation durvalumab at 1500 mg IV Day 1 of every 4 week cycle for up to 12 cycles.
Induction Durvalumab: Induction durvalumab at 1500 mg intravenously (IV) will be given on Day 1 of a four week cycle for 1 cycle,
Chemotherapy: Concurrent chemoradiation will be with platinum-based chemotherapy (cisplatin or carboplatin, with etoposide, taxane, or pemetrexed) selected at the treating physician's discretion. The chemotherapy regimen used should be administered per institutional standards following the prescribing guidelines for each drug
Radiation: Treatment will be delivered using IMRT or 3DCRT using typically 6-10MV photons per institutional standards. 4D simulation and appropriate IGRT are encouraged. Radiation therapy must begin within one week of the first day of chemotherapy (or vice versa). Therapy will be 1.8-2 Gy per day; 5 days per week, excluding holidays per institutional standard as this is a standard of care regimen for this patient population. 54-66 Gy will be delivered.
Consolidation durvalumab: Durvalumab at 1500 mg intravenously (IV) will be given on Day 1 of a four week cycle for 12 cycles
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|---|---|
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Age, Continuous
|
67 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
|
Histology at Study Entry
Adenocarcinoma
|
4 Participants
n=5 Participants
|
|
Histology at Study Entry
Adenosquamous
|
1 Participants
n=5 Participants
|
|
Histology at Study Entry
Squamous
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the time of treatment initiation until progression, up to 12 months12-month progression-free survival will be measured using imaging after completion of chemoradiation, prior to C1 consolidation durvalumab (1-42 days after completion of chemoradiation) per RECIST 1.1. RECIST 1.1 Criteria for Response are: Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started
Outcome measures
| Measure |
Induction Durvalumab, Chemoradiation, Consolidation Durvalumab
n=10 Participants
Induction durvalumab at 1500 mg intravenously (IV) on Day 1 of a four week cycle for 1 cycle, followed by concurrent definitive chemoradiation, followed by consolidation durvalumab at 1500 mg IV Day 1 of every 4 week cycle for up to 12 cycles.
Induction Durvalumab: Induction durvalumab at 1500 mg intravenously (IV) will be given on Day 1 of a four week cycle for 1 cycle,
Chemotherapy: Concurrent chemoradiation will be with platinum-based chemotherapy (cisplatin or carboplatin, with etoposide, taxane, or pemetrexed) selected at the treating physician's discretion. The chemotherapy regimen used should be administered per institutional standards following the prescribing guidelines for each drug
Radiation: Treatment will be delivered using IMRT or 3DCRT using typically 6-10MV photons per institutional standards. 4D simulation and appropriate IGRT are encouraged. Radiation therapy must begin within one week of the first day of chemotherapy (or vice versa). Therapy will be 1.8-2 Gy per day; 5 days per week, excluding holidays per institutional standard as this is a standard of care regimen for this patient population. 54-66 Gy will be delivered.
Consolidation durvalumab: Durvalumab at 1500 mg intravenously (IV) will be given on Day 1 of a four week cycle for 12 cycles
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|---|---|
|
12-Month Progression Free Survival (PFS)
|
30 percentage of participants
Interval 11.6 to 77.33
|
PRIMARY outcome
Timeframe: 12 monthsAll subjects receiving at least one dose of durvalumab will be evaluable for toxicity. The National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, will be used for toxicity grading. Please refer to the study calendar for the schedule of toxicity assessment.
Outcome measures
| Measure |
Induction Durvalumab, Chemoradiation, Consolidation Durvalumab
n=10 Participants
Induction durvalumab at 1500 mg intravenously (IV) on Day 1 of a four week cycle for 1 cycle, followed by concurrent definitive chemoradiation, followed by consolidation durvalumab at 1500 mg IV Day 1 of every 4 week cycle for up to 12 cycles.
Induction Durvalumab: Induction durvalumab at 1500 mg intravenously (IV) will be given on Day 1 of a four week cycle for 1 cycle,
Chemotherapy: Concurrent chemoradiation will be with platinum-based chemotherapy (cisplatin or carboplatin, with etoposide, taxane, or pemetrexed) selected at the treating physician's discretion. The chemotherapy regimen used should be administered per institutional standards following the prescribing guidelines for each drug
Radiation: Treatment will be delivered using IMRT or 3DCRT using typically 6-10MV photons per institutional standards. 4D simulation and appropriate IGRT are encouraged. Radiation therapy must begin within one week of the first day of chemotherapy (or vice versa). Therapy will be 1.8-2 Gy per day; 5 days per week, excluding holidays per institutional standard as this is a standard of care regimen for this patient population. 54-66 Gy will be delivered.
Consolidation durvalumab: Durvalumab at 1500 mg intravenously (IV) will be given on Day 1 of a four week cycle for 12 cycles
|
|---|---|
|
Evaluate the Safety and Feasibility of Induction Durvalumab Using NCI CTCAE v5.0 for Toxicity Grading.
Hiccups
|
1 participants
|
|
Evaluate the Safety and Feasibility of Induction Durvalumab Using NCI CTCAE v5.0 for Toxicity Grading.
Infusion Reaction
|
1 participants
|
|
Evaluate the Safety and Feasibility of Induction Durvalumab Using NCI CTCAE v5.0 for Toxicity Grading.
Anemia
|
2 participants
|
|
Evaluate the Safety and Feasibility of Induction Durvalumab Using NCI CTCAE v5.0 for Toxicity Grading.
Neutropenia
|
3 participants
|
|
Evaluate the Safety and Feasibility of Induction Durvalumab Using NCI CTCAE v5.0 for Toxicity Grading.
Thrombocytopenia
|
1 participants
|
|
Evaluate the Safety and Feasibility of Induction Durvalumab Using NCI CTCAE v5.0 for Toxicity Grading.
Alkaline Phosphate Increased
|
1 participants
|
|
Evaluate the Safety and Feasibility of Induction Durvalumab Using NCI CTCAE v5.0 for Toxicity Grading.
Anorexia
|
1 participants
|
|
Evaluate the Safety and Feasibility of Induction Durvalumab Using NCI CTCAE v5.0 for Toxicity Grading.
Anxiety
|
1 participants
|
|
Evaluate the Safety and Feasibility of Induction Durvalumab Using NCI CTCAE v5.0 for Toxicity Grading.
Chills
|
1 participants
|
|
Evaluate the Safety and Feasibility of Induction Durvalumab Using NCI CTCAE v5.0 for Toxicity Grading.
Constipation
|
1 participants
|
|
Evaluate the Safety and Feasibility of Induction Durvalumab Using NCI CTCAE v5.0 for Toxicity Grading.
Creatinine Increase
|
1 participants
|
|
Evaluate the Safety and Feasibility of Induction Durvalumab Using NCI CTCAE v5.0 for Toxicity Grading.
Diarrhea
|
1 participants
|
|
Evaluate the Safety and Feasibility of Induction Durvalumab Using NCI CTCAE v5.0 for Toxicity Grading.
Dizziness
|
1 participants
|
|
Evaluate the Safety and Feasibility of Induction Durvalumab Using NCI CTCAE v5.0 for Toxicity Grading.
Dyspnea
|
2 participants
|
|
Evaluate the Safety and Feasibility of Induction Durvalumab Using NCI CTCAE v5.0 for Toxicity Grading.
Fever
|
1 participants
|
|
Evaluate the Safety and Feasibility of Induction Durvalumab Using NCI CTCAE v5.0 for Toxicity Grading.
Hyperkalemia
|
1 participants
|
|
Evaluate the Safety and Feasibility of Induction Durvalumab Using NCI CTCAE v5.0 for Toxicity Grading.
Hypomagnesemia
|
1 participants
|
|
Evaluate the Safety and Feasibility of Induction Durvalumab Using NCI CTCAE v5.0 for Toxicity Grading.
Hypothyroidism
|
1 participants
|
|
Evaluate the Safety and Feasibility of Induction Durvalumab Using NCI CTCAE v5.0 for Toxicity Grading.
Insomnia
|
1 participants
|
|
Evaluate the Safety and Feasibility of Induction Durvalumab Using NCI CTCAE v5.0 for Toxicity Grading.
Mucositis/Mouth Pain
|
2 participants
|
|
Evaluate the Safety and Feasibility of Induction Durvalumab Using NCI CTCAE v5.0 for Toxicity Grading.
Odynophagia
|
1 participants
|
|
Evaluate the Safety and Feasibility of Induction Durvalumab Using NCI CTCAE v5.0 for Toxicity Grading.
Pruritis
|
1 participants
|
|
Evaluate the Safety and Feasibility of Induction Durvalumab Using NCI CTCAE v5.0 for Toxicity Grading.
Rash
|
5 participants
|
|
Evaluate the Safety and Feasibility of Induction Durvalumab Using NCI CTCAE v5.0 for Toxicity Grading.
Neuropathy
|
1 participants
|
SECONDARY outcome
Timeframe: 12 monthsORR will be measured using two timepoints, per RECIST 1.1. "ORR1" will be assessed using baseline imaging in comparison to imaging obtained after completion of induction durvalumab and chemoradiation. "ORR2" will be assessed using imaging after completion of induction durvalumab and chemoradiation in comparison to imaging obtained while receiving, and after completion of, consolidation durvalumab. RECIST 1.1 Criteria for response are as follows: Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest
Outcome measures
| Measure |
Induction Durvalumab, Chemoradiation, Consolidation Durvalumab
n=10 Participants
Induction durvalumab at 1500 mg intravenously (IV) on Day 1 of a four week cycle for 1 cycle, followed by concurrent definitive chemoradiation, followed by consolidation durvalumab at 1500 mg IV Day 1 of every 4 week cycle for up to 12 cycles.
Induction Durvalumab: Induction durvalumab at 1500 mg intravenously (IV) will be given on Day 1 of a four week cycle for 1 cycle,
Chemotherapy: Concurrent chemoradiation will be with platinum-based chemotherapy (cisplatin or carboplatin, with etoposide, taxane, or pemetrexed) selected at the treating physician's discretion. The chemotherapy regimen used should be administered per institutional standards following the prescribing guidelines for each drug
Radiation: Treatment will be delivered using IMRT or 3DCRT using typically 6-10MV photons per institutional standards. 4D simulation and appropriate IGRT are encouraged. Radiation therapy must begin within one week of the first day of chemotherapy (or vice versa). Therapy will be 1.8-2 Gy per day; 5 days per week, excluding holidays per institutional standard as this is a standard of care regimen for this patient population. 54-66 Gy will be delivered.
Consolidation durvalumab: Durvalumab at 1500 mg intravenously (IV) will be given on Day 1 of a four week cycle for 12 cycles
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|---|---|
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Objective Response Rate (ORR)
Complete Response
|
2 Participants
|
|
Objective Response Rate (ORR)
Partial Response
|
5 Participants
|
|
Objective Response Rate (ORR)
Stable Disease
|
3 Participants
|
Adverse Events
Induction Durvalumab, Chemoradiation, Consolidation Durvalumab
Serious events: 1 serious events
Other events: 10 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Induction Durvalumab, Chemoradiation, Consolidation Durvalumab
n=10 participants at risk
Induction durvalumab at 1500 mg intravenously (IV) on Day 1 of a four week cycle for 1 cycle, followed by concurrent definitive chemoradiation, followed by consolidation durvalumab at 1500 mg IV Day 1 of every 4 week cycle for up to 12 cycles.
Induction Durvalumab: Induction durvalumab at 1500 mg intravenously (IV) will be given on Day 1 of a four week cycle for 1 cycle,
Chemotherapy: Concurrent chemoradiation will be with platinum-based chemotherapy (cisplatin or carboplatin, with etoposide, taxane, or pemetrexed) selected at the treating physician's discretion. The chemotherapy regimen used should be administered per institutional standards following the prescribing guidelines for each drug
Radiation: Treatment will be delivered using IMRT or 3DCRT using typically 6-10MV photons per institutional standards. 4D simulation and appropriate IGRT are encouraged. Radiation therapy must begin within one week of the first day of chemotherapy (or vice versa). Therapy will be 1.8-2 Gy per day; 5 days per week, excluding holidays per institutional standard as this is a standard of care regimen for this patient population. 54-66 Gy will be delivered.
Consolidation durvalumab: Durvalumab at 1500 mg intravenously (IV) will be given on Day 1 of a four week cycle for 12 cycles
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|---|---|
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Musculoskeletal and connective tissue disorders
Muscle Weakness
|
10.0%
1/10 • Number of events 1 • From initiation of subject consent until off study, up to 3.5 years.
|
Other adverse events
| Measure |
Induction Durvalumab, Chemoradiation, Consolidation Durvalumab
n=10 participants at risk
Induction durvalumab at 1500 mg intravenously (IV) on Day 1 of a four week cycle for 1 cycle, followed by concurrent definitive chemoradiation, followed by consolidation durvalumab at 1500 mg IV Day 1 of every 4 week cycle for up to 12 cycles.
Induction Durvalumab: Induction durvalumab at 1500 mg intravenously (IV) will be given on Day 1 of a four week cycle for 1 cycle,
Chemotherapy: Concurrent chemoradiation will be with platinum-based chemotherapy (cisplatin or carboplatin, with etoposide, taxane, or pemetrexed) selected at the treating physician's discretion. The chemotherapy regimen used should be administered per institutional standards following the prescribing guidelines for each drug
Radiation: Treatment will be delivered using IMRT or 3DCRT using typically 6-10MV photons per institutional standards. 4D simulation and appropriate IGRT are encouraged. Radiation therapy must begin within one week of the first day of chemotherapy (or vice versa). Therapy will be 1.8-2 Gy per day; 5 days per week, excluding holidays per institutional standard as this is a standard of care regimen for this patient population. 54-66 Gy will be delivered.
Consolidation durvalumab: Durvalumab at 1500 mg intravenously (IV) will be given on Day 1 of a four week cycle for 12 cycles
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|---|---|
|
Blood and lymphatic system disorders
Anemia
|
20.0%
2/10 • Number of events 2 • From initiation of subject consent until off study, up to 3.5 years.
|
|
Blood and lymphatic system disorders
Neutropenia
|
30.0%
3/10 • Number of events 3 • From initiation of subject consent until off study, up to 3.5 years.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.0%
1/10 • Number of events 1 • From initiation of subject consent until off study, up to 3.5 years.
|
|
Investigations
Alkaline Phosphatase Increased
|
10.0%
1/10 • Number of events 1 • From initiation of subject consent until off study, up to 3.5 years.
|
|
Metabolism and nutrition disorders
Anorexia
|
10.0%
1/10 • Number of events 1 • From initiation of subject consent until off study, up to 3.5 years.
|
|
Psychiatric disorders
Anxiety
|
10.0%
1/10 • Number of events 1 • From initiation of subject consent until off study, up to 3.5 years.
|
|
General disorders
Chills
|
10.0%
1/10 • Number of events 1 • From initiation of subject consent until off study, up to 3.5 years.
|
|
Gastrointestinal disorders
Constipation
|
10.0%
1/10 • Number of events 1 • From initiation of subject consent until off study, up to 3.5 years.
|
|
Investigations
Creatinine Increase
|
10.0%
1/10 • Number of events 1 • From initiation of subject consent until off study, up to 3.5 years.
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
1/10 • Number of events 1 • From initiation of subject consent until off study, up to 3.5 years.
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10 • Number of events 1 • From initiation of subject consent until off study, up to 3.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
20.0%
2/10 • Number of events 2 • From initiation of subject consent until off study, up to 3.5 years.
|
|
General disorders
Fever
|
10.0%
1/10 • Number of events 1 • From initiation of subject consent until off study, up to 3.5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
10.0%
1/10 • Number of events 1 • From initiation of subject consent until off study, up to 3.5 years.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
10.0%
1/10 • Number of events 1 • From initiation of subject consent until off study, up to 3.5 years.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
10.0%
1/10 • Number of events 1 • From initiation of subject consent until off study, up to 3.5 years.
|
|
Endocrine disorders
Hypothyroidism
|
10.0%
1/10 • Number of events 1 • From initiation of subject consent until off study, up to 3.5 years.
|
|
General disorders
Infusion Reaction
|
10.0%
1/10 • Number of events 1 • From initiation of subject consent until off study, up to 3.5 years.
|
|
Psychiatric disorders
Insomnia
|
10.0%
1/10 • Number of events 1 • From initiation of subject consent until off study, up to 3.5 years.
|
|
Gastrointestinal disorders
Mucositis/Mouth Pain
|
20.0%
2/10 • Number of events 2 • From initiation of subject consent until off study, up to 3.5 years.
|
|
Gastrointestinal disorders
Odynophagia
|
10.0%
1/10 • Number of events 1 • From initiation of subject consent until off study, up to 3.5 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
1/10 • Number of events 1 • From initiation of subject consent until off study, up to 3.5 years.
|
|
Skin and subcutaneous tissue disorders
Rash
|
50.0%
5/10 • Number of events 5 • From initiation of subject consent until off study, up to 3.5 years.
|
|
Nervous system disorders
Neuropathy
|
10.0%
1/10 • Number of events 1 • From initiation of subject consent until off study, up to 3.5 years.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place