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Neoadjuvant Immunoradiation for Resectable Non-Small Cell Lung Cancer
Phase 2 trial testing Durvalumab in Non-Small Cell Lung Cancer in 9 participants. Terminated before completion.
| Lead sponsor | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 9 |
| Start date | 12 December 2017 |
| Primary completion | 4 November 2021 |
| Estimated completion | 23 May 2024 |
| Sites | 2 locations across Canada, United States |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins — full company profile →
Adults 18 to 100, any sex, with 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.
Number of participants experiencing adverse events as defined by CTCAE v4.0.
| Group | Value | 95% CI |
|---|---|---|
| Durvalumab With Radiation | 9 | |
| Durvalumab and Trememlimumab With Radiation | 0 |
Number of participants with stage III resectable NSCLC who received durvalumab or durvalumab plus tremelimumab concurrently with thoracic radiation (RT) in the pre-surgical window prior to surgical resection, for whom planned surgical resection was not delayed.
| Group | Value | 95% CI |
|---|---|---|
| Durvalumab With Radiation | 9 | |
| Durvalumab and Trememlimumab With Radiation | 0 |
Number of participants who experience post-operative death. Calculated through log-rank test and Cox proportional hazards (PH) model. The values in the table represent the number of participants who experienced post-operative death.
| Group | Value | 95% CI |
|---|---|---|
| Durvalumab With Radiation | 0 | |
| Durvalumab and Trememlimumab With Radiation | 0 |
Percentage of participants with major pathologic response (MPR), partial response (PR) or no response (NR), where MPR is \>90% reduction in tumor cells, PR = 10-90% or NR = 0-10%. The percentage of patients whose tumor samples achieve MPR, PR and NR will be tabulated.
| Group | Value | 95% CI |
|---|---|---|
| Durvalumab With Radiation | 9 | |
| Durvalumab and Trememlimumab With Radiation | 0 |
Percentage of participants with complete response (CR), partial response (PR), progressive disease (PD), and stable disease (SD) as defined by RECIST 1.1 and immune-related RECIST criteria when treated with preoperative immunoradiation followed by surgery. CR = disappearance of all target lesions, PR is =\>30% decrease in sum of diameters of target lesions, PD is \>20% increase in sum of diameters of target lesions, SD is \<30% decrease or \<20% increase in sum of diameters of target lesions.
| Group | Value | 95% CI |
|---|---|---|
| Durvalumab With Radiation | 7 | |
| Durvalumab and Trememlimumab With Radiation | 0 |
Time frame: Post-surgery, up to 3 months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Durvalumab With Radiation | Durvalumab and Trememlimum… |
|---|---|---|---|
| aspiration pneumonia | Respiratory, thoracic and mediastinal disorders | — | — |
| thromboembolic event | Vascular disorders | — | — |
| appendicitis | Infections and infestations | — | — |
| pneumothorax | Respiratory, thoracic and mediastinal disorders | — | — |
| atrial fibrillation | Cardiac disorders | — | — |
| aspiration | Respiratory, thoracic and mediastinal disorders | — | — |
| pleural effusion | Respiratory, thoracic and mediastinal disorders | — | — |
| Reaction | System | Durvalumab With Radiation | Durvalumab and Trememlimum… |
|---|---|---|---|
| fatigue | General disorders | — | — |
| constipation | Gastrointestinal disorders | — | — |
| chest wall pain | Musculoskeletal and connective tissue disorders | — | — |
| dyspnea | Respiratory, thoracic and mediastinal disorders | — | — |
| cough | Respiratory, thoracic and mediastinal disorders | — | — |
| pruritus | Skin and subcutaneous tissue disorders | — | — |
| sore throat | Respiratory, thoracic and mediastinal disorders | — | — |
| nausea | Gastrointestinal disorders | — | — |
| bone pain | Musculoskeletal and connective tissue disorders | — | — |
| back pain | Musculoskeletal and connective tissue disorders | — | — |
| diarrhea | Gastrointestinal disorders | — | — |
| rash maculo-papular | Skin and subcutaneous tissue disorders | — | — |
| vomiting | Gastrointestinal disorders | — | — |
| dizziness | Nervous system disorders | — | — |
| dry skin | Skin and subcutaneous tissue disorders | — | — |
| pain of skin | Skin and subcutaneous tissue disorders | — | — |
| esophageal pain | Gastrointestinal disorders | — | — |
| superficial thrombophlebitis | Vascular disorders | — | — |
| urinary urgency | Renal and urinary disorders | — | — |
| toothache | Gastrointestinal disorders | — | — |
| facial pain | General disorders | — | — |
| peripheral sensory neuropathy | Nervous system disorders | — | — |
| neutrophil count decreased | Investigations | — | — |
| acute kidney injury | Renal and urinary disorders | — | — |
| thrombophelbitis | Vascular disorders | — | — |
| fever | General disorders | — | — |
| chills | General disorders | — | — |
| myalgia | Musculoskeletal and connective tissue disorders | — | — |
| violaceus raticular rash - upper forearm | Skin and subcutaneous tissue disorders | — | — |
| erythematous rash - thighs and knees | Skin and subcutaneous tissue disorders | — | — |
| anterior chest rash | Skin and subcutaneous tissue disorders | — | — |
| arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| polyarthritis | Musculoskeletal and connective tissue disorders | — | — |
| joint pain | Musculoskeletal and connective tissue disorders | — | — |
| sinus disorder - sinus drainage | Respiratory, thoracic and mediastinal disorders | — | — |
| productive cough | Respiratory, thoracic and mediastinal disorders | — | — |
| orange-colored skin | Skin and subcutaneous tissue disorders | — | — |
| pain at thoracotomy | Respiratory, thoracic and mediastinal disorders | — | — |
| hypokalemia | Metabolism and nutrition disorders | — | — |
| hypertension | Vascular disorders | — | — |
Most-reported serious reactions: aspiration pneumonia, thromboembolic event, appendicitis, pneumothorax, atrial fibrillation, aspiration, pleural effusion.
Data from ClinicalTrials.gov NCT03237377 adverse events section.
This is a pilot study of neoadjuvant 'immunoradiation' (durvalumab or durvalumab plus tremelimumab) administered every 4 weeks for 2 doses, concurrently with standard thoracic radiation (RT) (45Gy in 25 fractions), with one dose of immunotherapy alone delivered in the pre-surgical window, prior to surgical resection, for patients with stage IIIA NSCLC that is deemed resectable with a lobectomy by a thoracic surgeon. If preliminary safety of the durvalumab/thoracic RT combination is established, a second cohort investigating the combination of durvalumab/tremelimumab/thoracic RT prior to surgical resection will be opened. After surgical resection, patients may receive standard adjuvant chemotherapy, as deemed appropriate by the treating investigator.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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