Trial · NCT07050043
Low Dose Nivolumab With Chemotherapy vs Standard Chemotherapy as First-Line Treatment in Advanced or Metastatic NSCLC
NCT07050043, Phase 3, Recruiting, Dr Arvindran A/L Alaga
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Low Dose Nivolumab With Chemotherapy vs Standard Chemotherapy as First-Line Treatment in Advanced or Metastatic NSCLC. Trials, record NCT07050043. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07050043
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Low Dose Nivolumab With Chemotherapy vs Standard Chemotherapy as First-Line Treatment in Advanced or Metastatic NSCLC
- NCT number
- NCT07050043
- Status
- Recruiting
- Phases
- Phase 3
- Enrollment
- 123 participants, estimated
- Lead sponsor
- Dr Arvindran A/L Alaga
- Conditions
- NSCLC (Non-small Cell Lung Carcinoma), First Line Therapy, Locally Advanced/Metastatic NSCLC
- Interventions
- Nivolumab 40mg, Cisplatin, Carboplatin, Pemetrexed, Gemcitabine, Paclitaxel, Docetaxel
- First posted
- 2025-07-03
- Last updated
- 2025-07-03
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) | From randomization to either the date of progression or death from any cause (whichever comes first) - up to 36 months | Determine the PFS of six-weekly Nivolumab 40mg combined with standard chemotherapy versus standard chemotherapy alone in NSCLC |
| Secondary | Overall Survival (OS) | From the date of treatment commencement to the date death from any cause or the date of the last follow-up before final analysis (whichever comes first) - up to 36 months | Evaluate the OS of six-weekly Nivolumab 40mg combined with standard chemotherapy in NSCLC |
| Secondary | Patient-Reported Outcome Measure (PROM) | From the baseline until the end of treatment follow up or the last study follow up related to adverse event - up to 24 months | Evaluate PROM for six-weekly Nivolumab 40mg combined with standard chemotherapy in NSCLC. For each tool, domain scores and individual scores will be calculated using the scoring or developer's guidelines |
| Secondary | PROM using EORTC QLQ-C30 | From the baseline until the end of treatment follow up or the last study follow up related to adverse event - up to 24 months | A 30-question survey that looks at overall quality of life in cancer patients. It measures five functional dimensions (physical, role, emotional, cognitive, and social), three symptom items (fatigue, nausea/vomiting, and pain), six single items (dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial impact) and global health and quality of life |
| Secondary | PROM using EQ-5D-5L | From the baseline until the end of treatment follow up or the last study follow up related to adverse event - up to 24 months | A 6-question tool to assess general health and well-being through 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression |
| Secondary | PROM using NSCLC-SAQ | From the baseline until the end of treatment follow up or the last study follow up related to adverse event - up to 24 months | A 7-question survey that focuses on lung cancer symptoms, including cough, dyspnea, pain, fatigue, and appetite |
| Secondary | Incidence of Treatment-Emergent Adverse Events (TEAEs) | From first dose to last dose of treatment plus follow-up - up to 27 months | To assess the safety and tolerability profile of study regimens, measured by the number and percentage of participants experiencing at least one TEAE, as defined by CTCAE v5.0 |
| Secondary | Incidence of Serious Adverse Events (SAEs) | From first dose to last dose of treatment plus follow-up - up to 27 months | To assess the safety and tolerability profile of study regimens, measured by the number and percentage of participants experiencing at least one SAE, as defined by CTCAE v5.0 |
| Secondary | Incidence of Treatment-Related Discontinuations | From first dose to last dose of treatment plus follow-up - up to 27 months | To assess the safety and tolerability profile of study regimens, measured by the number and percentage of participants who discontinue treatment due to adverse events, as defined by CTCAE v5.0 |
| Secondary | Incidence of Treatment-Related Deaths | From first dose to last dose of treatment plus follow-up - up to 27 months | To assess the safety and tolerability profile of study regimens, measured by the number and percentage of participants who die due to adverse events, as defined by CTCAE v5.0 |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT07050043
GET https://conductscience.org/api/trials/v1/NCT07050043/registered