Immune Profile Selection By Fraction of ctDNA in Patients With Advanced NSCLC Treated With Immunotherapy

NCT05715229 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: Pro2022-0016
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 3

Brief Summary

This clinical trial plans to assess to what extent the on-treatment circulating tumor DNA (ctDNA) can predict the subset of patients with NSCLC who will respond to immunotherapy treatment only and which patients will need both immunotherapy and chemotherapy modalities for their treatment regimen.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Advanced Non Small Cell Lung Cancer (NSCLC); Metastatic NSCLC; circulating tumor DNA (ctDNA); G360

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS)

  To compare progression free survival in patients with on-treatment-ctDNA guided therapy continuation or escalation by addition of platinum-doublet chemotherapy to therapy continuation with Nivolumab-Ipilimumab regardless of on-treatment-ctDNA results.

  Time from randomization to objective disease progression, or death from any cause, whichever first, up to 36 months

Secondary Outcomes (5)

• Progression Free Survival on Subsequent line of therapy (PFS2)

  Duration of time from randomization to second objective disease progression, or death from any cause, whichever first, up to 36 months

• Overall Survival

  Duration of time from first treatment to time of death, up to 36 months

• Objective Response Rate

  Duration of time between the date of first treatment and the date of objectively documented progression per irRECIST or the date of initiation of palliative local therapy or the date of subsequent anti-cancer therapy, whichever occurs first, up to 36 mo

• Duration of Response

  Duration of time between the date of first confirmed response to the date of the first documented tumor progression (per irRECIST), or death due to any cause, whichever occurs first, up to 36 months

• Safety and Tolerability

  All analyses will be conducted using the 30-day safety window

Study Arms (2)

Arm A

ACTIVE COMPARATOR

Arm A - Intervention arm (Immunotherapy and Chemotherapy) Nivolumab 360 mg/kg every 3 weeks Ipilimumab 1 mg/kg every 6 weeks Platinum- doublet Chemotherapy (Histology-based) 4 cycles depending on the investigator's discretion. Carboplatin dosed at AUC 5, and either Paclitaxel 175 mg/m2 for squamous or Pemetrexed 500 mg/m2 for non-squamous

Drug: Nivolumab; Drug: Ipilimumab; Drug: Carboplatin; Drug: Paclitaxel; Drug: Pemetrexed

Arm B

OTHER

Arm B - control arm (Immunotherapy only) Nivolumab 360 mg/kg every 3 weeks Ipilimumab 1 mg/kg every 6 weeks

Drug: Nivolumab; Drug: Ipilimumab

Interventions

Paclitaxel DRUG

Chemotherapy

Also known as: Taxol, Paxel

Arm A

Nivolumab DRUG

Immunotherapy

Also known as: Opdivo

Arm A; Arm B

Ipilimumab DRUG

Immunotherapy

Also known as: Yervoy

Arm A; Arm B

Carboplatin DRUG

Chemotherapy

Also known as: Paraplatin

Arm A

Pemetrexed DRUG

Chemotherapy

Also known as: Alimta, Pemfexy

Arm A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eligible patients will have newly diagnosed, previously untreated histologically documented Stage IV NSCLC
• Eligible patients will be required to have positive PD-L1 expression ≥1% by IHC using Dako 22C3 assay.
• Patients will require a baseline Guardant360 CDx test prior to enrollment
• Patients willing to undergo serial ctDNA testing as required by protocol
• Patients will be over the age of 18
• Life expectancy ≥12 weeks
• Measurable (RECIST 1.1) indicator lesion not previously irradiated, with measurable disease determined per the treating investigator.
• Prior palliative radiotherapy to non-CNS lesions must have been completed at least 2 weeks prior to randomization
• ECOG Performance Score ≤2
• Adequate organ function
• Hemoglobin \> 9 g/dL
• Platelets \> 100,000mm3 or 100 x 109/L
• AST, ALT \< 2.5 x ULN with no liver metastases or \< 5x ULN with the presence of liver metastases
• Total bilirubin \< 1.5 x ULN if no liver metastases or \< 3 x ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases
• Absolute neutrophil count (ANC) \> 1500 cells/mm3

You may not qualify if:

• Patients under the age of 18
• Inability to provide informed consent by either the patient or the authorized representative
• Patients with known EGFR, ALK, ROS1, MET, and RET oncogenic driver alterations that have approved first-line targeted therapies are excluded from the study (All patients must have a tissue or blood-based testing to identify these driver alterations)
• Patients with no detectable ctDNA or ctDNA VAF ≤ 0.3% on Guardant360 CDx at baseline
• Subjects with untreated CNS metastases are excluded.
• Subjects are eligible if CNS metastases are adequately treated and subjects are neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment) for at least 2 weeks prior to randomization. In addition, subjects must be either off corticosteroids, or on a stable or decreasing dose of 10 mg daily prednisone (or equivalent) for at least 2 weeks prior to randomization.
• Subjects with carcinomatous meningitis
• Subjects must have recovered from the effects of major surgery or significant traumatic injury at least 14 days before randomization
• Subjects with previous malignancies (except non-melanoma skin cancers, and in situ cancers such as the following: bladder, gastric, colon, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to randomization and no additional therapy is required or anticipated to be needed during the study period.
• Other active malignancy requiring concurrent intervention.
• Subjects with an active, known, or suspected autoimmune disease. Subjects with type I diabetes mellitus, and hypothyroidism only require hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
• Subjects with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids, and adrenal replacement steroids \> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
• Subjects with interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity.
• Significant uncontrolled cardiovascular disease, including but not limited to, any of the following:
• Uncontrolled hypertension, which is defined as systolic blood pressure \> 160 mm Hg or diastolic blood pressure \> 100 mm Hg despite optimal medical management.

Sponsors & Collaborators

• Hackensack Meridian Health: lead
• MedSIR: collaborator

Study Sites (3)

Lombardi Comprehensive Cancer Center, Georgetown University

Washington D.C., District of Columbia, 20007, United States

NOT YET RECRUITING

John Theurer Cancer Center, Hackensack Meridian Health

Hackensack, New Jersey, 07410, United States

RECRUITING

Jersey Shore University Medical Center

Neptune City, New Jersey, 07753, United States

NOT YET RECRUITING

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Related Links

• National Library of Medicine (US). 2021 Aug 16 - . Identifier NCT00527735; Phase II Study for Previously Untreated Subjects With Non Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC);
• How do OPDIVO® (nivolumab) and YERVOY® (ipilimumab) team up to fight cancer differently than chemotherapy

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Nivolumab; Ipilimumab; Carboplatin; Paclitaxel; Pemetrexed

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic

Study Officials

• Martin Gutierrez, MD

  Hackensack Meridian Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren Finaldi

CONTACT

551-996-5228; Lauren.Finaldi@hmhn.org

Suzanne Kosky

CONTACT

551-996-3986; Suzanne.Kosky@hmhn.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Subjects will be randomized 2:1 and patients in both arms will begin treatment with nivolumab 360 mg intravenously every 3 weeks and ipilimumab 1 mg/kg intravenously every 6 weeks. At five weeks of treatment, subjects will have ctDNA response evaluation with Guardant360 Response assay. At the next cycle of treatment (+/- 2 days), patients in the arm A will receive treatment based on the Guardant360 Response assay results, as described below. Arm B will continue the immunotherapy only.

Study Record Dates

• First Submitted: January 6, 2023
• First Posted: February 6, 2023
• Study Start: September 29, 2023
• Primary Completion (Estimated): April 28, 2027
• Study Completion (Estimated): April 28, 2027
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)