Trial Tested Lung Cancer Therapy Before Surgery
A new phase 2 clinical trial is investigating whether a combination of Leclaza and Rybrevant can shrink tumors before surgery.
Updated on Oct. 12, 2026 in Cancer
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Johnson & Johnson launched a phase 2 clinical trial on July 28, 2026, to test Leclaza and Rybrevant as a preoperative treatment for patients with EGFR-mutated non-small cell lung cancer. The study aims to evaluate if this combination therapy can effectively reduce tumor size and suppress micro-metastases prior to surgical intervention.
Why it matters
Reducing tumor size before an operation may improve surgical outcomes, though market access remains dependent on national health insurance reimbursement criteria given the high annual cost of €207,250 per patient. Understanding these preoperative options is vital for patients navigating treatment paths in the 23 countries involved in this research.
This phase 2 trial involves 68 patients with resectable EGFR-mutated non-small cell lung cancer across 23 international institutions. Researchers are building upon earlier findings from the European Lung Cancer Research Group, which reported a median overall survival of 19.9 months for a related triple therapy.
The players
Johnson & Johnson
A global pharmaceutical company that develops treatments for oncology and autoimmune conditions, including the combination of Leclaza and Rybrevant.
Yuhan Corporation
A South Korean pharmaceutical firm that researches oncology therapies and receives royalties based on the global sales of the Rybrevant and Leclaza combination.
The details
The trial evaluates neoadjuvant therapy, which is administered to reduce tumor size and address micro-metastases before the primary surgical procedure. The treatment utilizes Leclaza and Rybrevant, with subcutaneous formulations designed to shorten administration times and reduce the burden of hospital stays for patients compared to traditional intravenous delivery methods.
Timeline
October 2025: Commercialization of the therapy began in China.
March 2026: Leclaza was integrated into Germany's health insurance reimbursement system.
May 2026: Ireland's NCPE raised concerns regarding reimbursement recommendations.
July 28, 2026: Johnson & Johnson initiated the phase 2 clinical trial.
April 2028: The clinical trial is expected to reach its completion date.
Health Landscape
This development follows findings published by the European Lung Cancer Research Group and tests a shift toward preoperative administration for EGFR-mutated cancers. The global strategy focuses on scaling this combination therapy, supported by a $5 billion annual sales target for the product combination.
If you are managing EGFR-mutated non-small cell lung cancer, discussions with your doctor about clinical trials may provide access to new neoadjuvant treatment approaches. Be aware that the cost of these therapies is high and varies significantly by country, making it important to review your regional health insurance reimbursement coverage.
The takeaway
This trial investigates if clearing tumor cells before surgery can improve long-term survival in lung cancer patients. If you or a loved one are facing a new diagnosis, ask your oncologist about the potential benefits and eligibility requirements for clinical trials in your region.
What happens next
The clinical trial for this preoperative combination therapy is expected to conclude in April 2028, at which point further data on survival outcomes will be available.
Further reading
For more information on current treatment standards and ongoing research, explore the latest updates in Cancer.
More information
Find active studies and specific participation criteria on the clinical trial search portal.
Source note: This article includes information reported by 조선일보.
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