A Prospective Cohort Study of PD-1 Monoclonal Antibody Combined With Ipilimumab N01 and Chemotherapy in Perioperative Treatment of Resectable Non-small Cell Lung Cancer
NCT07917767, Phase 2, Not yet recruiting, Tang-Du Hospital
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Prospective Cohort Study of PD-1 Monoclonal Antibody Combined With Ipilimumab N01 and Chemotherapy in Perioperative Treatment of Resectable Non-small Cell Lung Cancer | ClinicalTrials.gov |
| NCT number | NCT07917767 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 2 | ClinicalTrials.gov |
| Enrollment | 90 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Tang-Du Hospital | ClinicalTrials.gov |
| Conditions | NSCLC Stage IIIA/B, NSCLC Stage II | ClinicalTrials.gov |
| Interventions | Cohort A, Cohort B | ClinicalTrials.gov |
| First posted | 2026-11-05 | ClinicalTrials.gov |
| Last updated | 2026-11-05 | ClinicalTrials.gov |
Registered outcomes 6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Pathological Complete Response (pCR) Rate | At the time of surgery, approximately 20 weeks after randomization | The pCR rate is defined as the proportion of participants with no residual viable tumor cells in the resected primary tumor and sampled regional lymph nodes (ypT0N0), as determined by histopathological examination following neoadjuvant treatment and surgical resection. The pCR rate will be assessed separately in each treatment cohort. | ClinicalTrials.gov |
| Secondary | Major Pathological Response (MPR) Rate | At the time of surgery, approximately 20 weeks after randomization | The MPR rate is defined as the proportion of participants with 10% or less residual viable tumor cells in the resected primary tumor, as determined by histopathological examination following neoadjuvant treatment and surgical resection. The MPR rate will be assessed separately in each treatment cohort. | ClinicalTrials.gov |
| Secondary | R0 Resection Rate | At the time of surgery, approximately 20 weeks after randomization | The R0 resection rate is defined as the proportion of participants who achieve complete surgical resection with microscopically negative resection margins, as confirmed by postoperative histopathological examination. | ClinicalTrials.gov |
| Secondary | On-Schedule Surgery Completion Rate | Within 22 to 42 days after the last dose of neoadjuvant treatment | The on-schedule surgery completion rate is defined as the proportion of participants who undergo curative-intent surgical resection within the protocol-specified window of 22 to 42 days after the last dose of neoadjuvant treatment. | ClinicalTrials.gov |
| Secondary | Safety and Tolerability of Neoadjuvant Treatment | From the first dose of neoadjuvant treatment through 90 days after surgery | Safety and tolerability will be evaluated based on the incidence and severity of adverse events (AEs), serious adverse events (SAEs), and treatment-related adverse events (TRAEs), assessed according to NCI-CTCAE version 5.0. The relationship of adverse events to study treatment will be determined by the investigator. Perioperative complications will be assessed using the Clavien-Dindo classification, and perioperative mortality will also be recorded. | ClinicalTrials.gov |
| Secondary | Health-Related Quality of Life (HRQoL) | During the first 12 months after surgery | Health-related quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and Lung Cancer Module 29 (EORTC QLQ-LC29). These questionnaires evaluate global health status, physical and functional well-being, lung cancer-related symptoms, and treatment-related adverse effects. Scores will be transformed to a 0-100 scale according to the EORTC scoring guidelines. Higher global health and functional scores indicate better quality of life, whereas higher symptom scores indicate greater symptom burden. | 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)