Using T-cell receptor patterns to predict response to first-line tislelizumab plus chemotherapy in extensive-stage small-cell lung cancer

Clinical Study on Using T Cell Repertoire Technology to Predict the Therapeutic Effect of Tislelizumab + Standard Chemotherapy in the First-line Treatment of Extensive-stage Small Cell Lung Cancer

This will test whether patterns in patients' T-cell receptors can predict how well first-line tislelizumab plus chemotherapy works for people with extensive-stage small-cell lung cancer.

Quick facts

• Study type: Observational
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Henan Cancer Hospital (Government)
• Drugs / interventions: tislelizumab, chemotherapy, immunotherapy
• Locations: 1 site (Zhengzhou, Henan)
• Trial ID: NCT07244016 on ClinicalTrials.gov

What this trial studies

This prospective observational study will enroll 40 treatment‑naive adults with extensive‑stage small‑cell lung cancer who are planned to receive first‑line tislelizumab combined with standard chemotherapy. Blood (and where available tumor) samples will undergo next‑generation sequencing to profile T‑cell receptor (TCR) repertoires at baseline and during treatment, and machine‑learning approaches will be applied to link TCR features with clinical outcomes measured by RECIST v1.1. No experimental drug assignment is made; patients receive standard‑of‑care immunochemotherapy and are followed for response and safety. The intent is to identify TCR signatures that predict who is likely to benefit from this first‑line regimen and to generate data for future validation studies.

Who should consider this trial

Good fit: Ideal candidates are adults (≥18 years) with histologically confirmed extensive‑stage SCLC who are treatment‑naive, have at least one measurable lesion, and an ECOG performance status of 0–1 (stable or asymptomatic treated brain metastases allowed).

Not a fit: Patients who have received prior systemic therapy for SCLC, have an ECOG score ≥2, require urgent chest radiotherapy, or cannot provide required samples are unlikely to benefit from participation in this observational biomarker study.

Why it matters

Potential benefit: If successful, the approach could help identify which patients are more likely to benefit from first‑line tislelizumab plus chemotherapy, allowing more personalized treatment decisions.

How similar studies have performed: TCR repertoire features and machine‑learning prediction have shown promise in non‑small‑cell lung cancer and other solid tumors, but similar predictive biomarker work in small‑cell lung cancer remains limited and largely exploratory.

Eligibility criteria

Inclusion Criteria:

* Histologically proven ES-SCLC (American Joint Cancer Commission (7th Edition) Stage IV SCLC \[any T, any N and M1a/b\]), or T3-4 patients who are unable to be included in a tolerable radiotherapy program due to wide multiple incidences or excessive tumor volume.
* Patients with brain metastases must have asymptomatic or stable steroid and anticonvulsant treatment for at least 1 month before study treatment. Patients with suspected brain metastasis during screening should undergo brain CT/MRI examination before enrollment of the study.
* Have at least one measurable tumour lesion according to RECIST v1.1.
* aged ≥18 years
* Eastern Cooperative Oncology Group (ECOG) physical status score of 0-1

Exclusion Criteria:

* Have a history of chest radiotherapy or plan to undergo intensive chest radiotherapy before systemic treatment. Radiotherapy outside the chest (i.e., bone metastasis) is allowed for palliative care purposes, however, must be done before the first medication of the study drug
* Previous non-infectious pneumonia requiring systemic glucocorticoid therapy or current non-infectious pneumonia combined with mild to moderate interstitial pneumonia, inactive interstitial pneumonia.
* Presence of unmitigated toxicity from prior antineoplastic therapy, with unmitigated defined as failure to recover to NCI CTCAE version 5.0 grade 0 or 1 (except alopecia areata) or failure to recover to levels specified in the inclusion/exclusion criteria.
* History of known allogeneic organ transplantation and allogeneic haematopoietic stem cell transplantation; history of organ or haematopoietic stem cell transplantation requiring immunosuppression.
* Patients with chronic hepatitis B or chronic hepatitis B virus carriers with HBV DNA ≥500 IU/mL (2500 copies/mL), or hepatitis C patients.
* Other circumstances as determined by the investigator.

Where this trial is running

Zhengzhou, Henan

• Henan Cancer Hosipital — Zhengzhou, Henan, China (Recruiting)

Study contacts

• Principal investigator: Chen Li Juan, Prof — Henan Cancer Hospital
• Study coordinator: Henan Province Cancer Hospital Ethics Committee Henan Province Cancer Hospital Ethics Committee

Conditions Extensive-stage Small-cell Lung Cancer