Trial · NCT07318883
A Phase II/III Clinical Study to Evaluate HLX07 in Combination With Serplulimab and Chemotherapy Versus Placebo in Combination With Serplulimab or Pembrolizumab and Chemotherapy as First-Line Treatment in Advanced Squamous Non-Small Cell Lung Cancer
NCT07318883, Phase 2, Phase 3, Not yet recruiting, Shanghai Henlius Biotech
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase II/III Clinical Study to Evaluate HLX07 in Combination With Serplulimab and Chemotherapy Versus Placebo in Combination With Serplulimab or Pembrolizumab and Chemotherapy as First-Line Treatment in Advanced Squamous Non-Small Cell Lung Cancer. Trials, record NCT07318883. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07318883
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
A Phase II/III Clinical Study to Evaluate HLX07 in Combination With Serplulimab and Chemotherapy Versus Placebo in Combination With Serplulimab or Pembrolizumab and Chemotherapy as First-Line Treatment in Advanced Squamous Non-Small Cell Lung Cancer
- NCT number
- NCT07318883
- Status
- Not yet recruiting
- Phases
- Phase 2, Phase 3
- Enrollment
- 720 participants, estimated
- Lead sponsor
- Shanghai Henlius Biotech
- Conditions
- Squamous NSCLC
- Interventions
- HLX07, HLX07 placebo, Serplulimab, Pembrolizumab, Carboplatin, Paclitaxel or Nab-Paclitaxel
- First posted
- 2026-01-06
- Last updated
- 2026-01-06
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | ORR assessed by BICR (part I) | Assessed up to appoximately 6 months from enrollment | Defined as the proportion of participants who achieve a best overall response of CR or PR |
| Primary | PFS assessed by BICR (part I) | Assessed up to appoximately 16 months from enrollment | Defined as the time from randomization to the first documentation of PD (RECIST v1.1) or death due to any cause (whichever occurs first) |
| Primary | PFS assessed by BICR (part II) | Assessed up to appoximately 23 months from enrollment | Defined as the time from randomization to the first documentation of PD (RECIST v1.1) or death due to any cause (whichever occurs first) |
| Primary | OS (part II) | Assessed up to appoximately 42 months from enrollment | Defined as the time from randomization to death due to any cause |
| Secondary | DCR (part I) | Assessed up to appoximately 6 months from enrollment | Defined as the proportion of participants who achieve a best overall response of CR or PR or an SD |
| Secondary | OS (part I) | Assessed up to appoximately 35 months from enrollment | Defined as the time from randomization to death due to any cause |
| Secondary | DOR (part I) | Assessed up to appoximately 35 months from enrollment | Defined as the time from the first documented objective response to PD or death |
| Secondary | ORR assessed by investigator (part I) | Assessed up to appoximately 6 months from enrollment | Defined as the proportion of participants who achieve a best overall response of CR or PR |
| Secondary | PFS assessed by investigator (part I) | Assessed up to appoximately 16 months from enrollment | Defined as the time from randomization to the first documentation of PD (RECIST v1.1) or death due to any cause (whichever occurs first) |
| Secondary | Incidence of adverse events (part I) | Assessed up to appoximately 35 months from enrollment |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes0
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/NCT07318883
GET https://conductscience.org/api/trials/v1/NCT07318883/registered