Evaluation of the Effect of Time of Administration on the Activity on First Line of Pembrolizumab in Association With Carboplatin-pemetrexed in Metastatic Non-squamous Lung Cancer. A Randomised Multicenter Phase III Trial
NCT07915037, Phase 3, Not yet recruiting, Assistance Publique - Hôpitaux de Paris
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Evaluation of the Effect of Time of Administration on the Activity on First Line of Pembrolizumab in Association With Carboplatin-pemetrexed in Metastatic Non-squamous Lung Cancer. A Randomised Multicenter Phase III Trial | ClinicalTrials.gov |
| NCT number | NCT07915037 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 3 | ClinicalTrials.gov |
| Enrollment | 254 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Assistance Publique - Hôpitaux de Paris | ClinicalTrials.gov |
| Conditions | Metastasic NSCLC | ClinicalTrials.gov |
| Interventions | Randomization of chemoimmunotherapy hour administration, Questionnaires, Exploratory study 1 (facultative), Exploratory study 2 (facultative), Exploratory study 3 (facultative) | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Survival rate | At one year (12 months) | Survival rate is defined as the survival probability at one year. | ClinicalTrials.gov |
| Secondary | Progression Free Survival (PFS) | Until all-cause death or tumor progression (monitored throughout the 24 months of the patient's participation) | PFS is defined as delay from randomisation until all-cause death or tumor progression whichever comes first | ClinicalTrials.gov |
| Secondary | Overall Survival (OS) | from randomisation until all-cause death (monitored throughout the 24 months of the patient's participation) | Overall Survival (OS) defined as delay from randomisation until all-cause death. | ClinicalTrials.gov |
| Secondary | Tumor respons | Over 1 year, and early response rate at 6 weeks from randomisation | Best tumor response rate and early response rate according to RECIST criteria | ClinicalTrials.gov |
| Secondary | Safety | Up to two years (28 months) | Adverse events categorized by severity and type, rated following CTCAE v.5.0 | ClinicalTrials.gov |
| Secondary | Quality of Life Index 1 | At the 16th cycle after randomization (48 weeks) | Quality of life according to the EQ-5D-5L test results | ClinicalTrials.gov |
| Secondary | Quality of Life Index 2 | At the 16h cycle after randomization (48 weeks) | Quality of life according to the EORTC QLQ C30 test results | ClinicalTrials.gov |
| Secondary | Quality of sleep index | At the 16th cycle after randomization (48 weeks) | Quality of sleep according to the Pittsburgh test results | ClinicalTrials.gov |
| Secondary | Chronotype assessment | At the 8th cycle after randomization (24 weeks) | Chronotype assesssments according to the Hörne-Ostberg test results | ClinicalTrials.gov |
| Secondary | Cost-Utility | Up to two years (28 months) | Health economics analysis, in particular through associated healthcare costs, additional GP or specialist consultations, and complementary treatments. | ClinicalTrials.gov |
| Secondary | Facultative Result (Exploratory study) | Up to two years (28 months) | Optimal time of administration through mathematical modelling | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
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 | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)