Trial · NCT02434081
NIvolumab COmbination With Standard First-line Chemotherapy and Radiotherapy in Locally Advanced Stage IIIA/B Non-Small Cell Lung Carcinoma
NCT02434081, Phase 2, Completed, ETOP IBCSG Partners Foundation; results first posted 2021-10-25
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. NIvolumab COmbination With Standard First-line Chemotherapy and Radiotherapy in Locally Advanced Stage IIIA/B Non-Small Cell Lung Carcinoma. Trials, record NCT02434081. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02434081
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- NIvolumab COmbination With Standard First-line Chemotherapy and Radiotherapy in Locally Advanced Stage IIIA/B Non-Small Cell Lung Carcinoma
- NCT number
- NCT02434081
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 94 participants, actual
- Lead sponsor
- ETOP IBCSG Partners Foundation
- Conditions
- Non-small Cell Lung Cancer Stage III
- Interventions
- Nivolumab
- First posted
- 2015-05-05
- Last updated
- 2026-08-24
- Other registries' IDs
- eudract:2014-005097-11
- Results first posted
- 2021-10-25
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Grade ≥3 Pneumonitis (CTCAE v4.0) up to 6 Months Post-radiotherapy | Time from enrolment until 6 months post-radiotherapy | It is defined as the number of patients reaching up to 6 months post-radiotherapy without any episode of CTCAE v4.0 grade ≥3 pneumonitis. It will be used as the primary endpoint for all patients followed for at least 6 months beyond radiotherapy. |
| Secondary | Progression-free Survival by RECIST v1.1 (PFS) | From the date of enrolment of the first patient up to 3 years, which is also 1 year after the enrolment of the last patient (i.e., from September 2016 to September 2019) | PFS, κey secondary endpoint, is defined as the time from the date of enrolment until first documented progression or death, if progression is not documented. For patients without a PFS event, censoring occurs at the last tumour assessment. Database cutoff: 18 September 2019 |
| Secondary | (Grade ≥3) Pneumonitis-free Rate | From the date of enrolment of the first patient up to 3 years, which is also 1 year after the enrolment of the last patient (i.e., from September 2016 to September 2019) | Rate of TFP3, evaluated at 1-year based on Kaplan-Meier method, where TFP3 is defined as the time from the date of enrolment until first documented pneumonitis of grade ≥3. |
| Secondary | Objective Response Rate (ORR) | From the date of enrolment of the first patient up to 3 years, which is also 1 year after the enrolment of the last patient (i.e., from September 2016 to September 2019) | Objective response rate (ORR) is defined as the percentage of patients with objective response (OR). OR was determined using the Response Evaluation Criteria in Solid Tumors (RECIST v1.1). OR is defined as the best overall response (Complete Response (disappearance of all target and non-target lesions; no new lesions) or Partial Response (≥decrease in the sum of the largest diameters of target lesions; no new lesions)) across all assessment points from enrollment to termination of trial treatment. Radiological tumour assessment was performed using CT scans. |
| Secondary | Time to Treatment Failure (TTF). | From the date of enrolment of the first patient up to 3 years, which is also 1 year after the enrolment of the last patient (i.e., from September 2016 to September 2019) | Time to treatment failure (TTF) is defined as time from enrolment to discontinuation of trial treatment for any reason. Disease progression, treatment toxicity, death, withdrawal and lost to follow-up which occurred after treatment completion are viewed as events. |
| Secondary | Overall Survival (OS) | From the date of enrolment of the first patient up to 4 years (i.e., from September 2016 to September 2020). | OS is defined as the time from the date of enrolment until death from any cause. The patients without OS event (death) were censored at their last follow-up date |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Grade ≥3 Pneumonitis (CTCAE v4.0) up to 6 Months Post-radiotherapy | Time from enrolment until 6 months post-radiotherapy | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Progression-free Survival by RECIST v1.1 (PFS) | From the date of enrolment of the first patient up to 3 years, which is also 1 year after the enrolment of the last patient (i.e., from September 2016 to September 2019) | ITT cohort | months | MEDIAN |
| SECONDARY | (Grade ≥3) Pneumonitis-free Rate | From the date of enrolment of the first patient up to 3 years, which is also 1 year after the enrolment of the last patient (i.e., from September 2016 to September 2019) | Estimate of 1-year TFP3% based on the safety cohort (N=77 pts) | percentage of participants | NUMBER |
| SECONDARY | Objective Response Rate (ORR) | From the date of enrolment of the first patient up to 3 years, which is also 1 year after the enrolment of the last patient (i.e., from September 2016 to September 2019) | ITT cohort | percentage of patients with OR | NUMBER |
| SECONDARY | Time to Treatment Failure (TTF). | From the date of enrolment of the first patient up to 3 years, which is also 1 year after the enrolment of the last patient (i.e., from September 2016 to September 2019) | based on ITT cohort | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | From the date of enrolment of the first patient up to 4 years (i.e., from September 2016 to September 2020). | ITT cohort | months | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Grade ≥3 Pneumonitis (CTCAE v4.0) up to 6 Months Post-radiotherapy | Chemo-radiotherapy With Concurrent Nivolumab | 71 | Participants | ||
| Progression-free Survival by RECIST v1.1 (PFS) | Chemo-radiotherapy With Concurrent Nivolumab | 12.7 | 95% Confidence Interval 10.1 to 22.8 | months | |
| (Grade ≥3) Pneumonitis-free Rate | Chemo-radiotherapy With Concurrent Nivolumab | 87.0 | 95% Confidence Interval 76.4 to 93.0 | percentage of participants | |
| Objective Response Rate (ORR) | Chemo-radiotherapy With Concurrent Nivolumab | 73.4 | 95% Confidence Interval 62.3 to 82.7 | percentage of patients with OR | |
| Time to Treatment Failure (TTF). | Chemo-radiotherapy With Concurrent Nivolumab | 9.2 | 95% Confidence Interval 6.4 to 12.4 | months | |
| Overall Survival (OS) | Chemo-radiotherapy With Concurrent Nivolumab | 38.8 | 95% Confidence Interval 26.8 to NA | months |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Concurrent CRT-Nivo | 79 | |
| Overall Study | COMPLETED | Concurrent CRT-Nivo | 31 | |
| Overall Study | NOT COMPLETED | Concurrent CRT-Nivo | 48 |
Source ClinicalTrials.gov
Adverse events82
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Concurrent CRT-Nivo | 36 | 77 | |
| other | Neutrophil count decreased | Blood and lymphatic system disorders | Concurrent CRT-Nivo | 25 | 77 | |
| other | Vertigo | Ear and labyrinth disorders | Concurrent CRT-Nivo | 4 | 77 | |
| other | Hypothyroidism | Endocrine disorders | Concurrent CRT-Nivo | 6 | 77 | |
| other | Hyperthyroidism | Endocrine disorders | Concurrent CRT-Nivo | 5 | 77 | |
| other | Dysphagia | Gastrointestinal disorders | Concurrent CRT-Nivo | 26 | 77 | |
| other | Esophagitis | Gastrointestinal disorders | Concurrent CRT-Nivo | 21 | 77 | |
| other | Nausea | Gastrointestinal disorders | Concurrent CRT-Nivo | 17 | 77 | |
| other | Diarrhea | Gastrointestinal disorders | Concurrent CRT-Nivo | 12 | 77 | |
| other | Vomiting | Gastrointestinal disorders | Concurrent CRT-Nivo | 10 | 77 |
1 to 10 of 82Source ClinicalTrials.gov
See all 82 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Concurrent CRT-Nivo | 37 | 79 |
| Total, other adverse events | Concurrent CRT-Nivo | 76 | 77 |
| Total, serious adverse events | Concurrent CRT-Nivo | 37 | 77 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02434081
GET https://conductscience.org/api/trials/v1/NCT02434081/events?page=2