A Phase III, Single-Arm Multicenter Study of Atezolizumab (Anti-PD-L1 Antibody) in High PD-L1 Expression, Chemotherapy-Naïve Patients With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer

Plain English Summary

A Study of Atezolizumab in High PD-L1 Expression, Chemotherapy-Naïve Patients With Stage IV Non-Squamous or Squamous Non-Small Cell Lung Cancer is a Phase 3 clinical trial sponsored by Hoffmann-La Roche studying Non-Small Cell Lung Cancer. This trial tests Atezolizumab, an immunotherapy drug, for patients with advanced non-small cell lung cancer. It is for patients whose cancer has a high level of PD-L1 and who have not received chemotherapy for their advanced cancer. Participants will receive Atezolizumab infusions, and will be monitored for side effects and treatment effectiveness. Alternative treatments may include chemotherapy, other immunotherapies, or targeted therapies, depending on the specific cancer characteristics. The trial aims to enroll 60 participants.

Official Summary

This is a Phase III, single arm, multicenter study designed to evaluate the efficacy and safety of atezolizumab in high PD-L1 expression, chemotherapy-naïve, without a sensitizing EGFR mutation or ALK translocation patients with stage IV non-squamous or squamous NSCLC.

Who Can Participate

Here is what you need to know about eligibility for this trial. Patients with Stage IV non-squamous or squamous non-small cell lung cancer. Must have high PD-L1 expression (TC3 or IC3) and no prior treatment for Stage IV disease. Must have good general health (ECOG 0 or 1) and adequate organ function. Patients with brain metastases or certain other active medical conditions may not be eligible. This trial is studying Non-Small Cell Lung Cancer, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome measures how long patients live overall, indicating the drug's potential to extend life in this specific group of lung cancer patients. The specific primary outcome measures are: Overall survival (OS) (Atezolizumab initiation to death from any cause (up to approximately 28 months)). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial addresses a need for effective treatments in advanced lung cancer patients with high PD-L1 expression who haven't responded to or received chemotherapy, potentially offering a new treatment As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Non-Small Cell Lung Cancer, where improved treatment options are needed.

Investor Insight

This trial is investigating a targeted immunotherapy for a specific lung cancer subtype, representing a significant market within oncology with potential for improved patient outcomes if successful. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage.

Is This Trial Right for Me?

Ask your doctor if your cancer has high PD-L1 expression and if you meet the other eligibility criteria. Understand that you will receive Atezolizumab infusions regularly and will need to attend study visits for monitoring. Be prepared for potential side effects and discuss any concerns with your healthcare team. The trial is being conducted at 18 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NA
• Model: SINGLE_GROUP
• Masking: NONE
• Enrollment: 60 participants

Interventions

• DRUG: Atezolizumab — Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by investigators.

Primary Outcomes

• Overall survival (OS) (Atezolizumab initiation to death from any cause (up to approximately 28 months))

Secondary Outcomes

• Progression-free survival (PFS) (Atezolizumab initiation to the first occurrence of disease progression or death from any cause (whichever occurs first), (up to approximately 28 months))
• OS Rate at 1-Year (Atezolizumab initiation to 1-year)
• OS Rate at 2-Year (Atezolizumab initiation to 2-year)
• Objective Response Rate (ORR) (Randomization up to approximately 34 months)
• Duration of Response (DOR) (Randomization up to approximately 34 months)

Full Eligibility Criteria

Inclusion Criteria:

* ECOG performance status of 0 or 1.
* Histologically or cytologically confirmed, Stage IV non-squamous or squamous NSCLC.
* No prior treatment for Stage IV non-squamous or squamous NSCLC.
* Patients who have received prior neo-adjuvant, adjuvant chemotherapy, radiotherapy, or chemo-radiotherapy with curative intent for non-metastatic disease must have experienced a treatment free interval of at least 6 months from enrollment since the last chemotherapy, radiotherapy, or chemo-radiotherapy cycle.
* Tumor TC3 or IC3, as determined by SP142 performed by a central laboratory on previously obtained archival tumor tissue or tissue obtained from a biopsy at screening.
* Measurable disease, as defined by RECIST v1.1.
* Adequate hematologic and end-organ function.
* Life expectancy ≥3 months.
* For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating.

Exclusion Criteria:

* Known sensitizing mutation in the EGFR gene or ALK fusion oncogene.
* Symptomatic, untreated, or actively progressing CNS metastases.
* Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for ≥2 weeks prior to enrollment.
* Current leptomeningeal disease.
* Uncontrolled tumor-related pain.
* Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
* Uncontrolled or symptomatic hypercalcemia.
* Malignancies other than NSCLC within 5 years prior to enrollment, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome.
* Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within at least 5 months after the last dose of atezolizumab.
* History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
* Known allergy or hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation.
* Active or history of autoimmune disease or immune deficiency.
* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
* Positive human immunodeficiency virus (HIV) test result at screening.
* Patients with active hepatitis B or active hepatitis C at screening.
* Active tuberculosis.
* Severe infections within 4 weeks prior to randomization, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia.
* Significant cardiovascular disease.

Trial Locations

• Beijing Tiantan Hospital,Capital Medical University, Beijing, China
• Xuanwu Hospital, Capital Medical University, Beijing, China
• Beijing Chest Hospital, Beijing, China
• The Third Xiangya Hospital Of Central South University, Changsha, China
• Daping Hospital of Third Military Medical University, Chongqing, China
• Fujian Cancer Hospital, Fuzhou, China
• Sir Run Run Shaw Hospital Zhejiang University, Hangzhou, China
• Anhui Province Cancer Hospital, Hefei, China
• The First Affiliated Hospital of Anhui Medical University, Hefei, China
• Linyishi Cancer Hospital, Linyi, China
• ...and 8 more locations

Frequently Asked Questions

Related Conditions

• Non-Small Cell Lung Cancer
• Lung Cancer
• Metastatic Lung Cancer
• Squamous Cell Carcinoma
• Adenocarcinoma
• Oncology
• Immunotherapy
• Targeted Therapy
• Cancer Treatment
• Advanced Cancer

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