Timing of Immunotherapy for Non-Small Cell Lung Cancer

Effect of Infusion Timing on Pathologic Response to Neoadjuvant Immunotherapy in Resectable Non-Small Cell Lung Cancer

Recruiting Phase 3 Interventional Study
Resectable Stage II-III Non-Small Cell Lung Cancer (NSCLC)
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
156 (estimated)
Sponsor
Hunan Province Tumor Hospital · Other
Who this trial is looking for

This trial is looking for adults with stage II-III lung cancer who can receive immunotherapy and chemotherapy before surgery. Participants will receive treatment either in the morning or afternoon and will be monitored for their response.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am between 18 and 75 years old.
  • I have resectable stage II to III non-small cell lung cancer.
  • I can receive immunotherapy and chemotherapy before surgery.
  • I have a good performance status.
  • I have not had any prior cancer treatment for my current lung cancer.
  • I have good bone marrow, liver, kidney, and heart function.
  • I can attend scheduled visits and follow treatment plans.
  • I have signed informed consent to participate.

You may not be able to join if

  • I have EGFR-sensitive mutations or ALK/ROS1 rearrangements.
  • I have uncontrolled brain metastases.
  • I have had another type of cancer in the last 3 years, except for certain skin cancers.
  • I have previously received therapy for lung cancer.
  • I have severe allergic reactions to PD-1 or PD-L1 inhibitors.
  • I have an active autoimmune disease needing strong treatment.
  • I have current infections like active HBV, HCV, or HIV.
  • I am pregnant or breastfeeding.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
This prospective study aims to investigate whether the time of day when immune checkpoint inhibitors (ICIs) are administered affects the efficacy of neoadjuvant immunotherapy in patients with resectable stage II-III non-small cell lung cancer (NSCLC). Eligible patients will receive standard-of-care neoadjuvant ICI plus platinum-based chemotherapy and be randomly assigned to either a morning infusi…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: Participants must meet all of the following criteria: 1. Age ≥18 and ≤75 years at the time of enrollment. 2. Histologically or cytologically confirmed diagnosis of resectable stage II to III non-small cell lung cancer (NSCLC). 3. Deemed suitable for neoadjuvant immunotherapy co…
Contacts

Yongchang Zhang, professor

+0086 13873123436

zhanglei1152@126.com

CONTACT