Integrative Analysis of Tumor Microenvironment and Optimization of Immunotherapy Duration in NSCL Cancer Patients (OPTIMUNELUNG)

Institut Bergonié

Status and phase: Active, not recruiting; Phase 2

Conditions: Non Small Cell Lung Cancer

Treatments: Drug: ICI treatment continuation; Drug: ICI treatment discontinuation

Study type: Interventional

Funder types: Other

Identifiers

NCT04880382

2020-005562-34 (EudraCT Number)

IB 2019-07

Details and patient eligibility

About

Non-comparative multicentric randomized study to assess long-term benefit of PD-1 inhibition in NSCLC patients who experienced a response between 6 and 12 months after initiation of ICI (immune checkpoint inhibitor PD1/PDL-1 blockade therapy)

Full description

Two-arm, non-comparative, prospective, multicentric, randomized study for early discontinuation of immune checkpoint inhibitor PD1/PDL-1 blockade therapy in non-small cell lung cancer patients who achieved objective response between 6 and 12 months after treatment onset.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Histologically or cytologically confirmed non-small cell lung carcinoma (squamous or non squamous).

2. Locally advanced/unresectable or metastatic disease.

3. For non-squamous histology, tumor with no oncogenic addiction: no activating EGFR mutation, no ALK or ROS1 rearrangement,

4. Treatment with ICI (immune checkpoint inhibitor PD1/PDL-1 blockade therapy):

   1. in first or second-line treatment as per market authorization. For patients in first line, ICI alone or ICI + chemotherapy,
   2. start of ICI treatment 6 to 12 months (+/- 2 weeks) before registration.

5. At least one measurable lesion according to the RECIST v1.1 criteria before ICI treatment onset and confirmed by centralized review (lesion in previously irradiated filed can be considered as measurable if progressive at inclusion according to RECIST v1.1). At least one site of disease must be uni-dimensionally ≥ 10 mm.

6. Patient with objective response according to RECIST v1.1 criteria at 6 months or more and less than 12 months after ICI treatment onset. Response must be confirmed by centralized review

7. At least one lesion that can be biopsied for research purpose.

8. Age ≥ 18.

9. Performance status < 2.

10. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to registration.

11. Patient with a social security in compliance with the French law (Loi Jardé).

12. Patient must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.

13. Voluntarily signed and dated written informed consent prior to any study specific procedure.

Exclusion criteria

1. Female who is pregnant or breast-feeding.
2. Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the subject in this study.
3. Hypersensitivity to one of the active substances or to one of the excipients
4. Any contraindication to pursue ICI treatment as per investigator judgement.
5. Previous enrolment in the present study.
6. Individual deprived of liberty or placed under legal guardianship.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Standard Arm A: treatment by ICI will be continued

Other group

Description:

After achieving objective response between 6 and 12 months after treatment onset, for these patients ICI treament will continue as per market authorization

Treatment:

Drug: ICI treatment continuation

Experimental Arm B: treatment by ICI will be discontinued

Experimental group

Description:

After achieving objective response between 6 and 12 months after treatment onset, for these patients first-line or second line regimen should be discontinued. Patients will be followed as per standard management.

Treatment:

Drug: ICI treatment discontinuation