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RecruitingLast updated: 30 April 2024

BO44178: This phase II study is comparing the effectiveness of two types of immunotherapies (RO7247669 and pembrolizumab) when given in addition to platinum-based chemotherapy (carboplatin, and paclitaxel or pemetrexed) in people with previously untreated locally advanced or metastatic non-small cell lung cancerA Phase II, Randomized, Multicenter, Double-Blind, Controlled Study of RO7247669 Plus Platinum-Based Chemotherapy Versus Pembrolizumab Plus Platinum-Based Chemotherapy in Patients With Previously Untreated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Clinical summary

Summary

Eligible participants will be randomly allocated to either the Experimental Arm or the Active Comparator Arm.

In Experimental Arm A, participants will receive RO7247669 + Platinum-Based Chemotherapy. Those participants with non-squamous cell (NSQ) non-small cell lung cancer (NSCLC) will receive induction treatment with blinded RO7247669 in combination with pemetrexed and carboplatin, all on Day 1 every 3 weeks for four 21-day cycles, followed by maintenance therapy every 3 weeks with blinded RO7247669 together with pemetrexed. Those participants with squamous cell (SQ) NSCLC will receive blinded RO7247669 in combination with paclitaxel and carboplatin, all on Day 1 every 3 weeks for four 21-day cycles, followed by blinded blinded RO7247669 (On Day 1) every 3 weeks.

In the Active Comparator Arm, participants will receive pembrolizumab + platinum-based chemotherapy. Those participants with NSQ NSCLC will receive induction treatment with blinded pembrolizumab in combination with pemetrexed and carboplatin, all on Day 1 every 3 weeks for four 21-day cycles, followed by maintenance therapy with blinded pembrolizumab together with pemetrexed every 3 weeks. Those participants with SQ NSCLC will receive blinded pembrolizumab in combination with paclitaxel and carboplatin, all on Day 1 every 3 weeks for four 21-day cycles, followed by blinded pembrolizumab (on Day 1) every 3 weeks.

Conditions

This trial is treating patients with locally advanced, unresectable (Stage IIIB/IIIC) or metastatic (Stage IV) non-small cell lung cancer

Cancer

Lung Cancers Lung cancer

Age

People18+

Phase

II

Trial Acronym

BO44178

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Hoffmann-La Roche

Scientific Title

A Phase II, Randomized, Multicenter, Double-Blind, Controlled Study of RO7247669 Plus Platinum-Based Chemotherapy Versus Pembrolizumab Plus Platinum-Based Chemotherapy in Patients With Previously Untreated Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Eligibility

Inclusion

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Histologically or cytologically documented locally advanced, unresectable (Stage IIIB/IIIC) or metastatic (Stage IV) NSCLC who are not eligible for curative surgery and/or definitive chemoradiotherapy
  • No prior systemic treatment for metastatic NSCLC
  • Known tumor PD-L1 status
  • Confirmed availability of representative tumor specimens
  • Measurable disease
  • Life expectancy of at least 12 weeks
  • Adequate hematologic and end-organ function
  • Negative for HIV, hepatitis B (HBV), and hepatitis C (HCV)
  • Adequate cardiovascular function

Exclusion

  • NSCLC known to have a mutation in the EGFR gene or an ALK fusion oncogene
  • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
  • Untreated or clinically unstable spinal cord confession
  • History of leptomeningeal disease
  • Uncontrolled tumor-related pain
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once a month or more frequently)
  • Uncontrolled or symptomatic hypercalcemia
  • Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, granulomatosis with polyangiitis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis, with exceptions defined by the protocol
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on the screening chest computed tomography (CT) scan
  • Active tuberculosis (TB) or untreated latent TB
  • Current treatment with anti-viral therapy for HBV or HCV
  • Significant cardiovascular disease within 3 months prior to randomization
  • Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study
  • History of malignancy other than NSCLC within 5 years prior to randomization, with the exception of malignancies with a negligible risk of metastasis or death e.g., 5-year OS] rate > 90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal breast carcinoma in situ, or Stage I uterine cancer
  • Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia, or any active infection that could affect patient safety
  • Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment
  • Prior allogeneic stem cell or solid organ transplantation
  • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications
  • Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during study treatment or within 5 months after the final dose of study treatment
  • Treatment with investigational therapy within 28 days prior to initiation of study treatment
  • Any anti-cancer therapy, including hormonal therapy, within 21 days prior to initiation of study treatment
  • Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including, but not limited to, anti-cytotoxic T lymphocyte-associated protein 4, anti-T cell immunoreceptor with Ig and tyrosine-based inhibition motif domains, anti-PD-1 and anti-PD-L1 therapeutic antibodies, and anti-LAG3) agents
  • Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin-2) within 4 weeks or 5 drug-elimination half lives (whichever is longer) prior to initiation of study treatment
  • Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [TNF] agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment
  • History of severe allergic anaphylactic reactions to chimeric or humanized antibodies, fusion proteins, or platinum-containing compounds
  • Known hypersensitivity to Chinese hamster ovary cell products or to any component of the tobemstomig or pembrolizumab formulation
  • Known allergy or hypersensitivity or other contraindication to any component of the chemotherapy regimen the patient may receive during the study
  • Pregnancy or breastfeeding

Inclusion

  • Your cancer has spread to other parts of the body.
  • Your cancer has not spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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