Consolidation Radiotherapy vs. Observation in Oligoresidual Advanced Non-Small Cell Lung Cancer After Chemo-Immunotherapy

Summary

This clinical study investigates whether adding local radiation therapy (radiotherapy) to standard maintenance therapy benefits patients with advanced non-small cell lung cancer (NSCLC) who have a limited number of residual tumors after initial treatment. The primary objective is to determine if adding targeted radiation therapy to residual lesions prolongs progression-free survival in NSCLC patients with "oligo-residual lesions" (5 or fewer tumors in no more than 3 organs) following first-line chemoimmunotherapy. Researchers hypothesize that combination therapy will slow cancer progression more effectively than maintenance therapy alone. Eligible participants include adults (18+) with advanced NSCLC who have completed 4-6 cycles of first-line chemoimmunotherapy, show limited residual disease on Positron Emission Tomography-Computed Tomography (PET-CT), and lack specific genetic mutations (Epidermal Growth Factor Receptor \[EGFR\], Anaplastic Lymphoma Kinase \[ALK\], etc.). Patients will be randomized into two groups: Experimental: Continuation of maintenance therapy (immunotherapy alone or with chemotherapy) plus local radiotherapy to all residual tumors Control: Continuation of maintenance therapy only The study aims to answer: Primary: Does adding radiotherapy slow cancer progression more effectively? Secondary: Does it improve overall survival, control residual disease, and what are its effects on safety and quality of life? Participants will: Be randomly assigned to a treatment group Receive their designated treatment Undergo regular check-ups and imaging scans Complete quality of life questionnaires Potentially provide blood samples for research This research will help determine optimal treatment approaches for this specific patient population to improve outcomes and quality of life.

Timeline

Start

2025-06-11

Primary completion

2027-09-01

Completion

2027-09-01

Publications

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• Background Dingemans AC, Hendriks LEL, Berghmans T, Levy A, Hasan B, Faivre-Finn C, Giaj-Levra M, Giaj-Levra N, Girard N, Greillier L, Lantuejoul S, Edwards J, O'Brien M, Reck M, Smit EF, Van Schil P, Postmus PE, Ramella S, Lievens Y, Gaga M, Peled N, Scagliotti GV, Senan S, Paz-Ares L, Guckenberger M, McDonald F, Ekman S, Cufer T, Gietema H, Infante M, Dziadziuszko R, Peters S, Porta RR, Vansteenkiste J, Dooms C, de Ruysscher D, Besse B, Novello S. Definition of Synchronous Oligometastatic Non-Small Cell Lung Cancer-A Consensus Report. J Thorac Oncol. 2019 Dec;14(12):2109-2119. doi: 10.1016/j.jtho.2019.07.025. Epub 2019 Aug 6.
• Background Pawlik TM, Scoggins CR, Zorzi D, Abdalla EK, Andres A, Eng C, Curley SA, Loyer EM, Muratore A, Mentha G, Capussotti L, Vauthey JN. Effect of surgical margin status on survival and site of recurrence after hepatic resection for colorectal metastases. Ann Surg. 2005 May;241(5):715-22, discussion 722-4. doi: 10.1097/01.sla.0000160703.75808.7d.
• Background Pastorino U, Buyse M, Friedel G, Ginsberg RJ, Girard P, Goldstraw P, Johnston M, McCormack P, Pass H, Putnam JB Jr; International Registry of Lung Metastases. Long-term results of lung metastasectomy: prognostic analyses based on 5206 cases. J Thorac Cardiovasc Surg. 1997 Jan;113(1):37-49. doi: 10.1016/s0022-5223(97)70397-0.
• Background Franceschini D, De Rose F, Cozzi S, Franzese C, Rossi S, Finocchiaro G, Toschi L, Santoro A, Scorsetti M. The use of radiation therapy for oligoprogressive/oligopersistent oncogene-driven non small cell lung cancer: State of the art. Crit Rev Oncol Hematol. 2020 Apr;148:102894. doi: 10.1016/j.critrevonc.2020.102894. Epub 2020 Feb 5.
• Background Kordbacheh T, Honeychurch J, Blackhall F, Faivre-Finn C, Illidge T. Radiotherapy and anti-PD-1/PD-L1 combinations in lung cancer: building better translational research platforms. Ann Oncol. 2018 Feb 1;29(2):301-310. doi: 10.1093/annonc/mdx790.
• Background Pitroda SP, Chmura SJ, Weichselbaum RR. Integration of radiotherapy and immunotherapy for treatment of oligometastases. Lancet Oncol. 2019 Aug;20(8):e434-e442. doi: 10.1016/S1470-2045(19)30157-3. Epub 2019 Jul 29.
• Background Van Limbergen EJ, De Ruysscher DK, Olivo Pimentel V, Marcus D, Berbee M, Hoeben A, Rekers N, Theys J, Yaromina A, Dubois LJ, Lambin P. Combining radiotherapy with immunotherapy: the past, the present and the future. Br J Radiol. 2017 Aug;90(1076):20170157. doi: 10.1259/bjr.20170157. Epub 2017 May 25.
• Background Zhou Y, Yu F, Zhao Y, Zeng Y, Yang X, Chu L, Chu X, Li Y, Zou L, Guo T, Zhu Z, Ni J. A narrative review of evolving roles of radiotherapy in advanced non-small cell lung cancer: from palliative care to active player. Transl Lung Cancer Res. 2020 Dec;9(6):2479-2493. doi: 10.21037/tlcr-20-1145.
• Background Ng CS, Wan IY, Yim AP. Impact of video-assisted thoracoscopic major lung resection on immune function. Asian Cardiovasc Thorac Ann. 2009 Aug;17(4):426-32. doi: 10.1177/0218492309338100.

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