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NCT Number: NCT06161441

A Trial to Learn if the Combination of Fianlimab, Cemiplimab, and Chemotherapy is Safe and Works Better Than the Combination of Cemiplimab and Chemotherapy in Adult Patients With Non-Small Cell Lung Cancer That Can be Treated With Surgery

This study is researching an experimental drug called fianlimab (also called REGN3767) with two other medications called cemiplimab and platinum-doublet chemotherapy, individually called a "study drug" or collectively called "study drugs", when combined in this study. The study is being conducted in patients who have resectable stage II to IIIB (N2) non-small cell lung cancer (NSCLC) that can be treated with surgery.

The aim of the study is to see how effective the combination of fianlimab, cemiplimab, and chemotherapy is in comparison with cemiplimab and chemotherapy as peri-operative therapy in participants with NSCLC.

The study is looking at several other research questions, including:

* What side effects may happen from taking the study drugs * How much of each study drug is in the blood at different times * Whether the body makes antibodies against the study drugs (which could make the drugs less effective or could lead to side effects) * How administering the study drugs might affect quality of life

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Resectable Non-small Cell Lung Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Eastern Health, Box Hill, Victoria, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Patients with newly diagnosed, histologically confirmed, fully resectable stage II to IIIB (N2) NSCLC as per American Joint Committee on Cancer (AJCC) version 8
  • For patients with evidence of mediastinal adenopathy on imaging, mediastinal lymph node sampling is required as defined in the protocol
  • All patients must have disease status showing no evidence of distant metastases documented by a complete physical examination and imaging studies performed within 4 weeks prior to randomization as defined in the protocol
  • A patient must have an evaluable Programmed cell death ligand-1 (PD-L1) immunohistochemistry (IHC) result as defined in the protocol
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate bone marrow, hepatic and kidney function as defined in the protocol

Key Exclusion Criteria:

  • Any evidence of locally advanced unresectable or metastatic disease as defined in the protocol
  • Patients with tumors with known Epidermal growth factor receptor (EGFR) gene mutations, anaplastic lymphoma kinase (ALK) gene translocations as defined in the protocol
  • Uncontrolled infection with human immunodeficiency virus (HIV), hepatitis B (HBV) or hepatitis C virus (HCV) infection as defined in the protocol
  • Treatment with anti-cancer therapy including immunotherapy, chemotherapy, radiotherapy, or biological therapy in the 3 years prior to randomization. Adjuvant hormonotherapy used for breast cancer or other hormone-sensitive cancers in long term remission is allowed.
  • Patients with a history of myocarditis

Note: Other protocol-defined Inclusion/ Exclusion Criteria apply

Treatment and study plan

Fianlimab

Drug

Administered intravenously (IV) every 3 weeks (Q3W)

Other names: REGN3767

cemiplimab

Drug

Administered IV Q3W

Other names: REGN2810, Libtayo

Pemetrexed

Drug

Administered IV Q3W

Other names: Alimta

paclitaxel

Drug

Administered IV Q3W

Other names: Taxol

carboplatin

Drug

Administered IV Q3W

Other names: Paraplatin

Cisplatin

Drug

Administered IV Q3W

Other names: Platinol

Placebo

Drug

Administered IV Q3W

Primary outcomes

  1. Pathological complete response (pCR) as evaluated by blinded independent pathological review (BIPR) in post-treatment resected tumor samples

    Time frame: Up to 24 months

Secondary outcomes

  1. Event-Free Survival (EFS)

    Time frame: Up to 3 years

  2. Major pathological response (MPR) by BIPR in post-treatment resected tumor samples

    Time frame: Up to 24 months

  3. MPR by local pathology review in post-treatment resected tumor samples

    Time frame: Up to 24 months

  4. Tumor response to neoadjuvant therapy per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) criteria by investigator assessment

    Time frame: Up to 24 months

  5. Occurrence of Adverse events (AEs)

    Time frame: Up to 5 years

  6. Occurrence of Treatment-emergent adverse event (TEAEs)

    Time frame: Up to 5 years

  7. Occurrence of Serious adverse events (SAEs)

    Time frame: Up to 5 years

  8. Occurrence of Adverse events of special interest (AESIs)

    Time frame: Up to 5 years

  9. Occurrence of immune-mediated adverse events (imAEs)

    Time frame: Up to 5 years

  10. Occurrence of interruption and discontinuation of study drug(s) due to TEAE

    Time frame: Up to 5 years

  11. Occurrence of laboratory abnormalities

    Time frame: Up to 5 years

    Grade ≥3 per National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE v5.0) including standard hematology, chemistry, urinalysis, and other lab tests

  12. Occurrence of death due to TEAE

    Time frame: Up to 5 years

  13. Concentrations of cemiplimab in serum

    Time frame: Up to 30 months

  14. Concentrations of fianlimab in serum

    Time frame: Up to 30 months

  15. Anti-drug antibodies (ADA) to fianlimab in serum over time

    Time frame: Up to 30 months

  16. ADA to cemiplimab in serum over time

    Time frame: Up to 30 months

  17. Percentage of patients with definitive surgery

    Time frame: Up to 24 months

  18. Percentage of patients with cancelled surgery

    Time frame: Up to 24 months

  19. Percentage of patients with delayed surgery

    Time frame: Up to 24 months

  20. Completeness of resection (R0, R1, R2, Rx)

    Time frame: Up to 24 months

  21. Length in delay of surgery

    Time frame: Up to 24 months

  22. Type of surgery (lobectomy, sleeve lobectomy, bilobectomy, pneumonectomy, other)

    Time frame: Up to 24 months

  23. Median length of hospital stay

    Time frame: Up to 24 months

  24. Surgical approach (thoracotomy, minimally invasive, minimally invasive to thoracotomy)

    Time frame: Up to 24 months

  25. Incidence of peri operative AE associated with surgery

    Time frame: Up to 90 days post-surgery

  26. Incidence of peri operative SAE associated with surgery

    Time frame: Up to 90 days post-surgery

  27. Incidence of post operative AE associated with surgery

    Time frame: Up to 90 days post-surgery

  28. Incidence of post operative SAE associated with surgery

    Time frame: Up to 90 days post-surgery

  29. Overall change in patient-reported global health status/QoL per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)

    Time frame: Up to 5 years

    EORTC-QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including a global health status/quality of life (GHS/QoL) scale. Participants rate items on a four-point scale, with 1 as "not at all" and 4 as "very much." A change of 5 - 10 points is considered a small change. A change of 10 - 20 points is considered a moderate change.

  30. Overall change in patient-reported physical functioning per EORTC QLQ-C30

    Time frame: Up to 5 years

  31. Overall change in patient-reported role functioning per EORTC QLQ-C30

    Time frame: Up to 5 years

  32. Overall change in patient-reported chest pain per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer 13 (EORTC QLQ-LC13)

    Time frame: Up to 5 years

    The EORTC QLQ-LC13 is a lung cancer-specific supplemental questionnaire used in combination with the EORTC QLQ-C30. Participant responses to the question "Have you had pain in your chest?" are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. The change from baseline in chest pain (EORTC QLQ-LC13 Item 40) score will be presented. A lower score indicates a better outcome.

  33. Overall change in patient-reported dyspnea per EORTC QLQ-LC13

    Time frame: Up to 5 years

  34. Overall change in patient-reported cough per EORTC QLQ-LC13

    Time frame: Up to 5 years

  35. Overall change in patient-reported composite of chest pain, dyspnea, and cough per EORTC QLQ-LC13

    Time frame: Up to 5 years

  36. Change in patient-reported general health status per EuroQoL 5-Dimensional 5-Level Scale (EQ-5D-5L) index

    Time frame: Up to 5 years

    The EQ-5D-5L descriptive system assesses 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated on a 5-level scale: no problems, slight problems, moderate problems, severe problems and extreme problems

  37. Change in patient-reported general health status per Visual analogue scale (VAS) scores

    Time frame: Up to 5 years

    The EQ-5D-5L VAS records the respondent's self-rated health on a 10 centimeter (cm) vertical, visual analogue scale. It is rated by the respondent on a scale 0 to 100, with 0 being "the worst health you can imagine" and 100 being "the best health you can imagine".

  38. Time until definitive deterioration in patient-reported global health status/QoL per EORTC QLQ-C30

    Time frame: Up to 5 years

  39. Time until definitive deterioration in patient-reported physical functioning per EORTC QLQ-C30

    Time frame: Up to 5 years

  40. Time until definitive deterioration in patient-reported role functioning per EORTC QLQ-C30

    Time frame: Up to 5 years

  41. Time until definitive deterioration in patient-reported chest pain per EORTC QLQ-LC13

    Time frame: Up to 5 years

  42. Time until definitive deterioration in patient-reported dyspnea per EORTC QLQ-LC13

    Time frame: Up to 5 years

  43. Time until definitive deterioration in patient-reported cough per EORTC QLQ-LC13

    Time frame: Up to 5 years

  44. Time until definitive deterioration in patient-reported composite of chest pain, dyspnea and cough per EORTC QLQ-LC13

    Time frame: Up to 5 years

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

A Phase 2 Peri-Operative Trial of Fianlimab and Cemiplimab in Combination With Chemotherapy Versus Cemiplimab in Combination With Chemotherapy in Patients With Resectable Early Stage (Stage II to IIIB [N2]) NSCLC

Important dates

Study start
2024
Primary completion
2026
Study completion
2029
First posted
Dec 7, 2023
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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