Trial · NCT02576574
Avelumab in First-line NSCLC (JAVELIN Lung 100)
NCT02576574, Phase 3, Completed, EMD Serono Research & Development Institute, Inc.; results first posted 2023-01-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Avelumab in First-line NSCLC (JAVELIN Lung 100). Trials, record NCT02576574. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02576574
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Avelumab in First-line NSCLC (JAVELIN Lung 100)
- NCT number
- NCT02576574
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,214 participants, actual
- Lead sponsor
- EMD Serono Research & Development Institute, Inc.
- Conditions
- First Line Non-Small Cell Lung Cancer
- Interventions
- Avelumab, Pemetrexed, Paclitaxel, Gemcitabine, Gemcitabine, Carboplatin, Cisplatin, Carboplatin, Avelumab Weekly
- First posted
- 2015-10-15
- Last updated
- 2025-01-31
- Other registries' IDs
- eudract:2015-001537-24
- Results first posted
- 2023-01-04
Source ClinicalTrials.gov
Registered outcomes32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) in High Programmed Death Ligand 1 (PD-L1) + Full Analysis Set (FAS) | Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months) | PFS is defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause in the absence of documented PD, whichever occurs first. PD is defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. PFS was measured using Kaplan-Meier (KM) estimates. |
| Primary | Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) in High Programmed Death Ligand 1 (PD-L1) + Modified Full Analysis Set (mFAS) | Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months) | PFS is defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause in the absence of documented PD, whichever occurs first. PD is defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. PFS was measured using Kaplan-Meier (KM) estimates. |
| Primary | Overall Survival (OS) in High Programmed Death Ligand 1 (PD-L1) + Full Analysis Set (FAS) | Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months) | OS is defined as the time from randomization to the date of death, regardless of the actual cause of the participant's death. The participants who were still alive at the time of data analysis or who were lost to follow-up OS time was censored at the last recorded date that the participant was known to be alive before the data cutoff date. OS was measured using Kaplan-Meier (KM) estimates. |
| Primary | Overall Survival (OS) in High Programmed Death Ligand 1 (PD-L1)+ Modified Full Analysis Set (mFAS) | Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months) | OS is defined as the time from randomization to the date of death, regardless of the actual cause of the participant's death. The participants who were still alive at the time of data analysis or who were lost to follow-up OS time was censored at the last recorded date that the participant was known to be alive before the data cutoff date. OS was measured using Kaplan-Meier (KM) estimates. |
| Secondary | Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) in Moderate and High Programmed Death Ligand 1 (PD-L1)+ Full Analysis Set (FAS) | Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months) | PFS is defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause in the absence of documented PD, whichever occurs first. PD is defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. PFS was measured using Kaplan-Meier (KM) estimates. |
| Secondary | Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) in Moderate and High Programmed Death Ligand 1 (PD-L1)+ Modified Full Analysis Set (mFAS) | Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months) | PFS is defined as the time from date of randomization until date of the first documentation of progressive disease (PD) or death due to any cause in the absence of documented PD, whichever occurs first. PD is defined as at least a 20 percent (%) increase in the sum of the longest diameter (SLD), taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions. PFS was measured using Kaplan-Meier (KM) estimates. |
| Secondary | Overall Survival (OS) in Moderate and High Programmed Death Ligand 1 (PD-L1)+ Full Analysis Set (FAS) | Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months) | OS is defined as the time from randomization to the date of death, regardless of the actual cause of the participant's death. The participants who were still alive at the time of data analysis or who were lost to follow-up OS time was censored at the last recorded date that the participant was known to be alive before the data cutoff date. OS was measured using Kaplan-Meier (KM) estimates. |
| Secondary | Overall Survival (OS) in Moderate and High Programmed Death Ligand 1 (PD-L1)+ Modified Full Analysis Set (mFAS) | Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months) | OS is defined as the time from randomization to the date of death, regardless of the actual cause of the participant's death. The participants who were still alive at the time of data analysis or who were lost to follow-up OS time was censored at the last recorded date that the participant was known to be alive before the data cutoff date. OS was measured using Kaplan-Meier (KM) estimates. |
| Secondary | Overall Survival (OS) in Full Analysis Set (FAS) | Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months) | OS is defined as the time from randomization to the date of death, regardless of the actual cause of the participant's death. The participants who were still alive at the time of data analysis or who were lost to follow-up OS time was censored at the last recorded date that the participant was known to be alive before the data cutoff date. OS was measured using Kaplan-Meier (KM) estimates. |
| Secondary | Overall Survival (OS) in Modified Full Analysis Set (mFAS) | Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months) | OS is defined as the time from randomization to the date of death, regardless of the actual cause of the participant's death. The participants who were still alive at the time of data analysis or who were lost to follow-up OS time was censored at the last recorded date that the participant was known to be alive before the data cutoff date. OS was measured using Kaplan-Meier (KM) estimates. |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 registered outcomesOutcomes32
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) in High Programmed Death Ligand 1 (PD-L1) + Full Analysis Set (FAS) | Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months) | High PD-L1+ FAS included all high expression PD-L1+ participants who were randomized to study intervention. High expression PD-L1+ participants with greater than or equal to (\>=) 80 percent (%) of tumor cells deemed positive for PD-L1 expression at any staining intensity (1+, 2+, or 3+). | months | MEDIAN |
| PRIMARY | Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) in High Programmed Death Ligand 1 (PD-L1) + Modified Full Analysis Set (mFAS) | Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months) | High PD-L1+ mFAS included all high expression PD-L1+ participants who were randomized to study intervention after weekly Avelumab was included into the randomization allocation. The PDL1+ participants with \>= 80% of tumor cells deemed positive for PD-L1 expression at any staining intensity (1+, 2+, or 3+). | months | MEDIAN |
| PRIMARY | Overall Survival (OS) in High Programmed Death Ligand 1 (PD-L1) + Full Analysis Set (FAS) | Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months) | High PD-L1+ FAS included all high expression PD-L1+ participants who were randomized to study intervention. High expression PD-L1+ participants with greater than or equal to (\>=) 80 percent (%) of tumor cells deemed positive for PD-L1 expression at any staining intensity (1+, 2+, or 3+). | months | MEDIAN |
| PRIMARY | Overall Survival (OS) in High Programmed Death Ligand 1 (PD-L1)+ Modified Full Analysis Set (mFAS) | Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months) | High PD-L1+ mFAS included all high expression PD-L1+ participants who were randomized to study intervention after weekly Avelumab was included into the randomization allocation. The PDL1+ participants with \>= 80% of tumor cells deemed positive for PD-L1 expression at any staining intensity (1+, 2+, or 3+). | months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) in Moderate and High Programmed Death Ligand 1 (PD-L1)+ Full Analysis Set (FAS) | Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months) | Moderate and High PD-L1+ FAS included all high expression PDL-L1+ participants who were randomized to study intervention. The PD-L1+ participants with \>= 50% of tumor cells deemed positive for PD-L1 expression at any staining intensity (1+, 2+, or 3+). | months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) in Moderate and High Programmed Death Ligand 1 (PD-L1)+ Modified Full Analysis Set (mFAS) | Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months) | Moderate and High PD-L1+ mFAS included all high expression PD-L1+ participants who were randomized to study intervention after weekly avelumab was included into the randomization allocation. The PD-L1+ participants with \>= 50% of tumor cells deemed positive for PD-L1 expression at any staining intensity (1+, 2+, or 3+). | months | MEDIAN |
| SECONDARY | Overall Survival (OS) in Moderate and High Programmed Death Ligand 1 (PD-L1)+ Full Analysis Set (FAS) | Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months) | Moderate and High PD-L1+ FAS included all high expression PD-L1+ participants who were randomized to study intervention. The PD-L1+ participants with \>= 50% of tumor cells deemed positive for PD-L1 expression at any staining intensity (1+, 2+, or 3+). | months | MEDIAN |
| SECONDARY | Overall Survival (OS) in Moderate and High Programmed Death Ligand 1 (PD-L1)+ Modified Full Analysis Set (mFAS) | Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months) | Moderate and High PD-L1+ mFAS included all high expression PD-L1+ participants who were randomized to study intervention after weekly avelumab was included into the randomization allocation. The PD-L1+ participants with \>= 50% of tumor cells deemed positive for PD-L1 expression at any staining intensity (1+, 2+, or 3+). | months | MEDIAN |
| SECONDARY | Overall Survival (OS) in Full Analysis Set (FAS) | Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months) | FAS included all participants who were randomized to study intervention. | months | MEDIAN |
| SECONDARY | Overall Survival (OS) in Modified Full Analysis Set (mFAS) | Time from date of randomization up to data cutoff (assessed up to approximately 71.5 months) | mFAS included all participants who were randomized to study intervention after weekly avelumab was included into the randomization allocation. | months | MEDIAN |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 outcomesResults by group639
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) in High Programmed Death Ligand 1 (PD-L1) + Full Analysis Set (FAS) | Avelumab Biweekly | 8.4 | 95% Confidence Interval 5.4 to 12.6 | months | |
Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) in High Programmed Death Ligand 1 (PD-L1) + Full Analysis Set (FAS) | Chemotherapy | 5.6 | 95% Confidence Interval 5.4 to 6.8 | months | |
Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) in High Programmed Death Ligand 1 (PD-L1) + Modified Full Analysis Set (mFAS) | Avelumab Weekly | 7.5 | 95% Confidence Interval 4.2 to 11.1 | months | |
Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) in High Programmed Death Ligand 1 (PD-L1) + Modified Full Analysis Set (mFAS) | Chemotherapy | 5.6 | 95% Confidence Interval 5.0 to 6.8 | months | |
| Overall Survival (OS) in High Programmed Death Ligand 1 (PD-L1) + Full Analysis Set (FAS) | Avelumab Biweekly | 20.1 | 95% Confidence Interval 15.0 to 24.3 | months | |
| Overall Survival (OS) in High Programmed Death Ligand 1 (PD-L1) + Full Analysis Set (FAS) | Chemotherapy | 14.9 | 95% Confidence Interval 11.8 to 18.6 | months | |
| Overall Survival (OS) in High Programmed Death Ligand 1 (PD-L1)+ Modified Full Analysis Set (mFAS) | Avelumab Weekly | 19.3 | 95% Confidence Interval 14.0 to 28.1 | months | |
| Overall Survival (OS) in High Programmed Death Ligand 1 (PD-L1)+ Modified Full Analysis Set (mFAS) | Chemotherapy | 15.3 | 95% Confidence Interval 11.6 to 19.1 | months | |
Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) in Moderate and High Programmed Death Ligand 1 (PD-L1)+ Full Analysis Set (FAS) | Avelumab Biweekly | 6.9 | 95% Confidence Interval 5.4 to 9.6 | months | |
Progression Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Assessed by Independent Review Committee (IRC) in Moderate and High Programmed Death Ligand 1 (PD-L1)+ Full Analysis Set (FAS) | Chemotherapy | 5.6 | 95% Confidence Interval 5.5 to 6.6 | months |
1 to 10 of 639Source ClinicalTrials.gov
See all 639 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Avelumab Biweekly | 366 | |
| Overall Study | STARTED | Avelumab Weekly | 322 | |
| Overall Study | STARTED | Chemotherapy | 526 | |
| Overall Study | COMPLETED | Avelumab Biweekly | 366 | |
| Overall Study | COMPLETED | Avelumab Weekly | 322 | |
| Overall Study | COMPLETED | Chemotherapy | 526 | |
| Overall Study | NOT COMPLETED | Avelumab Biweekly | 0 | |
| Overall Study | NOT COMPLETED | Avelumab Weekly | 0 | |
| Overall Study | NOT COMPLETED | Chemotherapy | 0 |
Source ClinicalTrials.gov
Adverse events1,134
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 | Asthenia | General disorders | Avelumab Biweekly | 58 | 361 | |
| other | Asthenia | General disorders | Avelumab Weekly | 54 | 318 | |
| other | Asthenia | General disorders | Chemotherapy | 74 | 500 | |
| other | Fatigue | General disorders | Avelumab Biweekly | 58 | 361 | |
| other | Fatigue | General disorders | Avelumab Weekly | 56 | 318 | |
| other | Fatigue | General disorders | Chemotherapy | 99 | 500 | |
| other | Pyrexia | General disorders | Avelumab Biweekly | 51 | 361 | |
| other | Pyrexia | General disorders | Avelumab Weekly | 50 | 318 | |
| other | Pyrexia | General disorders | Chemotherapy | 32 | 500 | |
| other | Chills | General disorders | Avelumab Biweekly | 28 | 361 |
1 to 10 of 1,134Source ClinicalTrials.gov
See all 1,134 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Avelumab Biweekly | 279 | 366 |
| Total, all-cause mortality | Avelumab Weekly | 237 | 322 |
| Total, all-cause mortality | Chemotherapy | 405 | 526 |
| Total, other adverse events | Avelumab Biweekly | 331 | 361 |
| Total, other adverse events | Avelumab Weekly | 298 | 318 |
| Total, other adverse events | Chemotherapy | 474 | 500 |
| Total, serious adverse events | Avelumab Biweekly | 181 | 361 |
| Total, serious adverse events | Avelumab Weekly | 143 | 318 |
| Total, serious adverse events | Chemotherapy | 195 | 500 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37748693 | RESULT |
Source PubMed
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
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