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Chemoradiation Followed by Durvalumab in Poor Risk and/or Elderly Patients With Stage III NSCLC
Phase 2 trial testing Durvalumab in Stage III Non-small-cell Lung Cancer in 10 participants. Terminated before completion.
| Lead sponsor | Rush University Medical Center |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 25 February 2021 |
| Primary completion | 31 March 2024 |
| Estimated completion | 31 March 2024 |
| Sites | 1 location across United States |
Rush University Medical Center
18 and older, any sex, with Stage III Non-small-cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
To determine the percentage of poor risk and/or elderly unresectable stage III NSCLC patients who complete split course chemoradiation. Objective will be assessed as a binary endpoint of yes/no completion for each patient.
| Group | Value | 95% CI |
|---|---|---|
| Concurrent, Split Course Chemoradiation Followed by Durvalumab | 8 |
To determine the safety and tolerability of durvalumab (MEDI4736) after completion of chemoradiation in this group of patients. Objective will be measured by (a) the number of cycles of durvalumab received for each treated patient and (b) the binary endpoint of discontinuation of durvalumab.
| Group | Value | 95% CI |
|---|---|---|
| Concurrent, Split Course Chemoradiation Followed by Durvalumab | 4 | ± 4.96 |
To determine the 1-year overall survival rate
| Group | Value | 95% CI |
|---|---|---|
| Concurrent, Split Course Chemoradiation Followed by Durvalumab | 8 |
To determine the 1-year progression-free survival rate based on the EORTC RECIST 1.1 criteria for solid tumors as follows: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative i
| Group | Value | 95% CI |
|---|---|---|
| Concurrent, Split Course Chemoradiation Followed by Durvalumab | 5 |
To determine the 1-year loco-regional progression-free survival rate, based on the EORTC RECIST 1.1 criteria for solid tumors as follows: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to
| Group | Value | 95% CI |
|---|---|---|
| Concurrent, Split Course Chemoradiation Followed by Durvalumab | 5 |
To determine rate of grade 3 and 4 toxicities with this regimen in the selected patient population
| Group | Value | 95% CI |
|---|---|---|
| Concurrent, Split Course Chemoradiation Followed by Durvalumab | 20 |
Time frame: 1 year. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Concurrent, Split Course C… |
|---|---|---|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — |
Data from ClinicalTrials.gov NCT04441138 adverse events section.
Elderly (age 70 years or older) or \>18 years old AND poor risk (ECOG 2) newly diagnosed stage IIIA-C (AJCC 8th edition) inoperable non-small cell lung cancer (NSCLC) patients are eligible to participate in this phase II open label study of concurrent, split course chemoradiation followed by Durvalumab (MEDI4736).
1 peer-reviewed publication reference this trial (live from Europe PMC):
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