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Phase II Trial: Low-Dose Radiation + SBRT + Sintilimab + Chemotherapy vs. Sintilimab + Chemotherapy in Locally Advanced or Metastatic Squamous Cell Lung Cancer

ConditionLung Squamous Cell Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSichuan University

About this trial

This is a randomized, controlled, open-label, multicenter phase II clinical trial comparing the efficacy and safety of low-dose radiation therapy and stereotactic body radiation therapy combined with PD-1 inhibitor (sintilimab) and standard platinum-based doublet chemotherapy versus PD-1 inhibitor (sintilimab) combined with standard platinum-based doublet chemotherapy as first-line treatment in patients with locally advanced or metastatic squamous cell lung cancer.

There will be 57 subjects in the experimental group and 57 subjects in the control group, with a total of 114 subjects.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years old and ≤ 75 years old;

Histologically or cytologically confirmed squamous cell lung cancer, imaging confirmed locally advanced or metastatic disease (unresectable or not eligible for definitive chemoradiotherapy, stage IIIB-IV);

According to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1), there is at least one imaging measurable lesion;

Enough to provide quality control qualified tumor tissue or cell wax blocks to detect PD-L1 expression;

Disqualifiers

The pathology is small cell lung cancer (SCLC), including lung cancer mixed with SCLC and non-small cell lung cancer (NSCLC)；

The pathology is lung adenocarcinoma, including lung cancer mixed with lung adenocarcinoma and lung squamous cell carcinoma;

EGFR gene sensitive mutation or ALK fusion positive or ROS1 fusion positive;

Previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or another drug that stimulates or synergistically inhibits T cell receptors;

Trial design

Design model

Parallel

Treatments tested in this trial

  • low-dose radiation therapy and stereotactic body radiation therapy

    Radiation

    Patients will receive radiation therapy.

  • chemotherapy

    Drug

    Patients will receive sintilimab combined with standard platinum-based doublet chemotherapy for a total of 4 cycles. Patients subsequently received maintenance treatment with sintilimab, and continued treatment until disease progression (PD), intolerable toxicity, withdrawal of informed consent, initiation of other anti-tumor treatments, death, or other circumstances that should stop treatment as specified in the protocol. Whichever occurs first. The maximum treatment time with sintilimab is 24 months (or 35 cycles).

  • Sintilimab

    Drug

    Patients will receive sintilimab combined with standard platinum-based doublet chemotherapy for a total of 4 cycles. Patients subsequently received maintenance treatment with sintilimab, and continued treatment until disease progression (PD), intolerable toxicity, withdrawal of informed consent, initiation of other anti-tumor treatments, death, or other circumstances that should stop treatment as specified in the protocol. Whichever occurs first. The maximum treatment time with sintilimab is 24 months (or 35 cycles).

Treatment groups

114 Participants
are divided into 2 treatment groups
Group A: Radiotherapy combined with sintilimab and chemotherapyExperimental treatment 3 interventions
Group B: Sintilimab+ChemotherapyActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

objective response rate (ORR)

The proportion of subjects with complete response (CR) or partial response (PR) in the analyzed population as judged by the investigator according to RECIST v1.1 criteria. ORR = (number of subjects with CR + PR) / total number of subjects \* 100%.

Time frame
Every 6 weeks (±7 days) from the first dose of study drug, and every 12 weeks (±7 days) after 48 weeks (up to 24 months).

Secondary outcomes

1

6-month PFS rate

The 6-month PFS rate is defined as the proportion of patients who did not experience disease progression or death from any cause at the time of 6 months.

Time frame
From date of randomization to 6 months.
2

1-year PFS rate

The 1-year PFS rate is defined as the proportion of patients who did not experience disease progression or death from any cause at the time of 1 year.

Time frame
From date of randomization to 1 years.
3

overall survival(OS)

OS is defined as the time from randomization to the death of the subject from any cause.

Time frame
From date of randomization to the time when the subject died from any cause, assessed up to 36 months.
4

Progression-free survival (PFS)

Progression-free survival (PFS) is defined as the time from randomization to first imaging disease progression or death, whichever occurs first.

Time frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sichuan University

Lead sponsor

Innovent Biologics (Suzhou) Co. Ltd.

Collaborator

Source ClinicalTrials.gov
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