Timing of immunochemotherapy for lung cancer treatment

Progression Survival Time According to Time-of-Day (ToD) of Administration of Immunochemotherapy for Advanced Non-small Cell Lung Cancer: A Phase III Randomized Control Trial

This study is testing if giving immunochemotherapy for lung cancer in the morning works better than in the afternoon for patients who haven't been treated before.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 210 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Hunan Province Tumor Hospital (Academic / other)
• Drugs / interventions: sunvozertinib, anlotinib, chemotherapy, immunotherapy, radiation, pembrolizumab, sitilimab, sintilimab
• Locations: 1 site (Changsha, Hunan)
• Trial ID: NCT05549037 on ClinicalTrials.gov

What this trial studies

This study investigates the effect of the time-of-day when administering immunochemotherapy on the progression-free survival of patients with treatment-naive advanced non-small cell lung cancer (NSCLC). Participants will be randomized into two groups: one receiving treatment in the morning and the other in the afternoon. The treatment involves chemotherapy combined with either pembrolizumab or sintilimab. The goal is to determine if the timing of administration influences treatment efficacy.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with confirmed advanced NSCLC who have not received prior systemic treatment.

Not a fit: Patients with prior systemic therapy for locally advanced or metastatic disease will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment outcomes for patients with advanced non-small cell lung cancer.

How similar studies have performed: While the specific timing of immunochemotherapy is a novel approach, similar studies have shown that timing can influence treatment outcomes in other contexts.

Eligibility criteria

Inclusion Criteria:

1. Understand the requirements and contents of the clinical trial, and provide a signed and dated informed consent form.
2. Age ≥ 18 years.
3. Histopathology or cytology confirmed and recorded local progression or metastatic non-small cell lung cancer without systemic treatment.
4. EGFR, ALK and ROS1 mutations negative confirmed by an accredited local laboratory.
5. ECOG 0-1.
6. Predicted survival ≥ 12 weeks.
7. Adequate bone marrow hematopoiesis and organ function
8. Presence of measurable lesions according to RECIST 1.1.
9. Subjects with stable brain metastases may be included in the study.

Exclusion Criteria:

1. Prior systemic therapy for locally advanced or metastatic disease.
2. Subjects who have received any of the following treatments must be excluded:

   * Ant Treatment with chemotherapy or molecules such as EGFR, VEGFR antibodies within 4 weeks prior to the first dose of study drug.
   * Have received radiation within 14 days prior to the first dose or have not recovered from radiation-related toxicity. Chest and extra-brain palliative radiotherapy, stereotactic radiosurgery, and stereotactic body radiotherapy may be performed 7 days prior to the first dose.
3. Presence of spinal cord compression or meningeal metastasis.
4. History of other malignant tumors within 2 years.
5. Adverse events (except alopecia of any degree) of CTCAE \> grade 1 due to prior treatment (e.g., adjuvant chemotherapy, radiotherapy, etc.) prior to the first dose.
6. History of stroke or intracranial hemorrhage within 6 months prior to the first dose.
7. The presence of any severe or poorly controlled systemic disease, including poorly controlled hypertension and active bleeding in the judgment of the investigator.
8. Subjects with persistent or active infection, including but not limited to hepatitis B (HBV), hepatitis C (HCV), human immunodeficiency virus (HIV) and COVID-19 infection.
9. Heart-related diseases or abnormalities
10. Past history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy or interstitial lung disease with active clinical symptoms, immune pneumonia caused by immunotherapy.
11. Refractory nausea and vomiting, chronic gastrointestinal disease, difficulty swallowing drugs, or inability to adequately absorb sunvozertinib or anlotinib due to previous bowel resection.
12. Live vaccine was given 2 weeks before the first medication.
13. Women who are breastfeeding or pregnant.
14. Hypersensitivity to the test drug and the ingredients.
15. Other conditions assessed by the investigator to be unsuitable for participation in the study.

Where this trial is running

Changsha, Hunan

• Hunan Cancer Hospital — Changsha, Hunan, China (Recruiting)

Study contacts

• Principal investigator: Yongchang Zhang, MD — Hunan Cancer Hospital
• Study coordinator: Yongchang C Zhang, MD

Conditions Non-small Cell Lung Cancer; Immunochemotherapy; Time of day