ClinicalTrials.gg
Status unknownNCT06586697Updated Sep 19, 2024

First-line Treatment for ES-SCLC with Chemotherapy Combined with PD-1/PD-L1 Inhibitor Sequential Thoracic Radiotherapy

A Phase 2 interventional study of Thoracic Radiotherapy in Extensive-stage Small-cell Lung Cancer, sponsored by Henan Cancer Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Henan Cancer Hospital · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2023), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Dec 2023, registered May 2024).
Phase
Phase 2
Study type
Interventional
Enrollment
47
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This is an open-label, single arm Phase II study designed to observe and evaluate the efficacy and safety of sequential thoracic radiotherapy in the first-line treatment of extensive small cell lung cancer with chemotherapy combined with approved PD-1/PD-L1 inhibitors.

Read the detailed description

This study a single arm prospective phase II study. All the enrolled patients will be patients with ES-SCLC who did not have PD after 4-6 cycle of platinum-based chemotherapy in combination with an PD-1/PD-L1 inhibitors. Then, those enrolled patients would be treated with thoracic radiotherapy concurrently with PD-1/PD-L1 maintenance therapy.

02

Conditions studied

  • Extensive-stage Small-cell Lung Cancer
03

In context

Small Cell Lung Carcinoma

1,234 studies on the registry are indexed under Small Cell Lung Carcinoma; 350 are open to participants now.

This study's planned enrollment of 47 is below the median of 56 across 1,058 interventional studies indexed under Small Cell Lung Carcinoma.

Browse Small Cell Lung Carcinoma studies →

Lead sponsor

Henan Cancer Hospital is the lead sponsor of 234 studies on the registry; 130 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age between18 years and 75 years.
  2. Histologic or cytologic confirmation of extensive-stage small cell lung cancer.
  3. Initially treated patients with extensive SCLC showed no disease progression after 4-6 cycles of chemotherapy combined with PD-1/PD-L1 inhibitors.
  4. Presence of at least one measurable lesion (according to RECIST v1.1).
  5. ECOG performance status of 0 or 1.
  6. Life expectancy of at least 3 months.
  7. Adequate bone marrow, liver and kidney function.
  8. Adequate pulmonary function with FEV1 >1 L or >30 % of predicted value and DLCO >30 % of predicted value

Exclusion criteria

Exclusion Criteria:

  1. Previous T cell co-stimulation or immune checkpoint therapy.
  2. Previous received chemoradiotherapy for limited-stage SCLC.
  3. Central nervous system metastasis with clinical symptoms.
  4. Multiple liver metastases (patients with isolated liver metastases, metastatic lesions \< 3cm could be included).
  5. Patients with spinal cord compression.
  6. Idiopathic pulmonary fibrosis, institutional pneumonia, drug-induced pneumonia or idiopathic pneumonia, or evidence of active pneumonia during screening (patients with active pulmonary tuberculosis couldn't be enrolled).
  7. Have received any other investigational drug treatment or participated in another interventional clinical study within 4 weeks prior to signing the informed consent.
  8. In the 5 years prior to the study, subjects had prior or concurrent malignancies requiring active treatment.
  9. Subjects with any severe and/or uncontrolled disease (hypertension, heart disease, infection, cirrhosis, active hepatitis, AIDS, third space effusion).
  10. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
  11. Severe allergic reactions to any of the monoclonal antibodies are known to occur.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
47 participants (estimated)

Study arms

  • Experimental
    Thoracic Radiotherapy

    Thoracic Radiotherapy (45Gy /1.5Gy/bid/3w)

    Radiation: Thoracic Radiotherapy

Interventions

  • RadiationThoracic Radiotherapy

    Thoracic Radiotherapy (45Gy /1.5Gy/bid/3w)

06

What researchers measure

Primary outcomes

  1. progression-free survival rate at 6-month

    PFS is defined as the period from the start of receiving the first line chemotherapy plus PD-1/PD-L1 inhibitor to disease progression.

    Time frame: 12 months after last patient entry

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06586697
Responsible party
Sponsor
First posted
Sep 19, 2024
Start date
Dec 1, 2023
Primary completion
Jan 1, 2026 (estimated)
Completion
Mar 20, 2026 (estimated)
Last update
Sep 19, 2024

Study contacts

Yang Liu
Contact
zlyyliuyang1440@zzu.edu.cn
13676961186

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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