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Study on the Optimal Combination Pattern of the Combined Treatment of Radiotherapy and Immunotherapy for the Abscopal Effect in Non-Small Cell Lung Cancer (NSCLC) With Multiple Metastases

ConditionNSCLC Stage IV Without EGFR/ALK Mutation
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorXinqiao Hospital of Chongqing

About this trial

This study aims to conduct a prospective, multicenter, umbrella clinical study to compare the abscopal effects of different radiotherapy fractionation patterns combined with Benmelstobart, and to explore an efficient and low-toxic treatment strategy for non-small cell lung cancer (NSCLC) with multiple metastases. The main objective is to explore and compare the control rates of abscopal lesions in NSCLC patients with multiple metastases when different radiotherapy fractionation patterns are combined with Benmelstobart.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Non-small cell lung cancer confirmed by pathological histology.

More than 3 metastatic lesions.

No brain metastases or stable lesions.

Negative for driver genes (including EGFR, ALK, ROS, BRAF, MET, RET).

Disqualifiers

Those with severe dysfunction of important vital organs (heart, liver, kidney).

Those accompanied by other malignant tumors.

Uncontrolled heart diseases or myocardial infarction within the past 6 months.

Those with a history of mental illness.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Benmelstobart combined with chemotherapy

    Drug

    After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no progression, the patient will receive the treatment of 6-10Gy\*3-6F plus Benmelstobart.

  • Benmelstobart combined with chemotherapy

    Drug

    After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no progression and the largest lesion measures between 3 cm and 5 cm, the patient will receive the treatment of 3 Gy \* 15 fractions plus Benmelstobart.

  • Benmelstobart combined with chemotherapy

    Drug

    After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no disease progression and the largest lesion is larger than 5 cm, the patient will receive treatment with Spatial Fractionated Radiotherapy Technique (SFRT) plus Benmelstobart.

  • Benmelstobart combined with chemotherapy

    Drug

    After 4 cycles of treatment with Benmelstobart combined with chemotherapy, if there is no disease progression, and when the largest lesion is ≤ 3 cm and the patient can maintain the radiotherapy position for 50 minutes, the patient will receive treatment with the hyperfractionated pulsed radiotherapy technique (0.5 Gy \* 16 \* 6 fractions) plus Benmelstobart.

  • Benmelstobart combined with chemotherapy

    Drug

    After 4 cycles of treatment with Benmelstobart combined with chemotherapy, Benmelstobart is continued for maintenance treatment.

  • Benmelstobart combined with Bevacizumab and chemotherapy

    Drug

    For eligible subjects who have developed resistance to EGFR-TKI, after 4 cycles of treatment with Benmelstobart combined with Bevacizumab and chemotherapy, if there is no disease progression, they will receive the treatment of 6-10Gy \* 3-6 fractions plus Benmelstobart.

Treatment groups

366 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Group AExperimental treatment 1 intervention
Group B: Group BExperimental treatment 1 intervention
Group C: Group CExperimental treatment 1 intervention
Group D: Group DExperimental treatment 1 intervention
Group E: Group EExperimental treatment 1 intervention
Group F: Group FExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The remission rate of abscopal lesions

To evaluate the efficacy of Benmelstobart plus different radiotherapy fractionation modes in non-small cell lung cancer (NSCLC) patients with multiple metastases, as measured by the remission rate of abscopal lesions according to RECIST v1.1

Time frame
From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to approximately 2 years

Secondary outcomes

1

PFS

To evaluate the efficacy of Benmelstobart plus different radiotherapy fractionation modes in non-small cell lung cancer (NSCLC) patients with multiple metastases, as measured by progression-free survival rate according to RECIST v1.1

Time frame
From date of randomization, until disease progression , loss of clinical benefit ,withdrawal of consent, death, or study termination by the Sponsor, whichever occurs first. Up to approximately 2 years
2

OS

To evaluate the efficacy of Benmelstobart plus different radiotherapy fractionation modes in non-small cell lung cancer (NSCLC) patients with multiple metastases, as measured by by overall survival

Time frame
up to 5 years
3

AE

The incidence of immune-related adverse events (irAEs) as assessed by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Time frame
From date of consent informed until 60 days after the last investigational product administration. Up to approximately 2 years

Other outcomes

Sponsors and contacts

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

Xinqiao Hospital of Chongqing

Lead sponsor

Source ClinicalTrials.gov
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