Christopher G. Azzoli, Sherman Baker, Jr., Sarah Temin, William Pao, Timothy Aliff, Julie Brahmer, David H. Johnson, Janessa L. Laskin, Gregory Masters, Daniel Milton, Luke Nordquist, David G. Pfister, Steven Piantadosi, Joan H. Schiller, Reily Smith, Thomas J. Smith, John R. Strawn, David Trent, Giuseppe Giaccone

Special Announcement: The US Food and Drug Administration (FDA) approved a new indication for pemetrexed for maintenance therapy in patients with advanced NSCLC on July 2, 2009, when this guideline went to press. The data supporting this change have been recently presented and were outside the scope of the comprehensive data review for this guideline. The recommendation on maintenance therapy in this guideline will be updated pending consideration of recently published relevant data.


Objective: To provide updated recommendations for the treatment of patients with stage IV non-small cell lung cancer.

Methods: A literature search identified relevant randomized trials published since 2002. The scope of the guideline was narrowed to chemotherapy and biological therapy. An Update Committee reviewed the literature and made updated recommendations.

Results: 162 publications met the inclusion criteria.

Recommendations: Recommendations were based on treatment strategies that improve overall survival. Treatments which improve only progression-free survival prompted scrutiny of toxicity and quality of life. For first-line therapy in patients with performance status 0 or 1, a platinum-based two-drug combination of cytotoxic drugs is recommended. Non-platinum cytotoxic doublets are acceptable for those with contraindications to platinum therapy. For patients with performance status 2, a single cytotoxic drug is sufficient. Stop first-line cytotoxic chemotherapy at disease progression, or after four cycles in patients who are not responding to treatment. Stop two-drug cytotoxic chemotherapy at six cycles even in patients who are responding to therapy. The first-line use of gefitinib may be recommended for patients with known EGFR mutation; for negative or unknown EGFR mutation status, cytotoxic chemotherapy is preferred. Bevacizumab is recommended with carboplatin-paclitaxel, except for those with certain clinical characteristics. Cetuximab is recommended with cisplatin-vinorelbine for patients with EGFR-positive tumors by immunohistochemistry. Docetaxel, erlotinib, gefitinib, or pemetrexed are recommended as second-line therapy. Erlotinib is recommended third-line therapy for patients who have not received prior erlotinib or gefitinib. Data are insufficient to recommend the routine third-line use of cytotoxic drugs. Data are insufficient to recommend routine use of molecular markers to select chemotherapy.


ASCO’s practice guidelines reflect expert consensus based on clinical evidence and literature available at the time they are written and are intended to assist physicians in clinical decision-making and identify questions and settings for further research. Due to the rapid flow of scientific information in oncology, new evidence may have emerged since the time a guideline was submitted for publication. Guidelines are not continually updated and may not reflect the most recent evidence. Guidelines address only the topics specifically identified in the guideline and are not applicable to interventions, diseases or stages of disease not specifically identified. Guidelines cannot account for individual variation among patients and cannot be considered inclusive of all proper methods of care or exclusive of other treatments. It is the responsibility of the treating physician or other health care provider, relying on independent experience and knowledge of the patient, to determine the best course of treatment for the patient. Accordingly, adherence to any guideline is voluntary, with the ultimate determination regarding its application to be made by the physician in light of each patient's individual circumstances and preferences. ASCO guidelines describe the use of procedures and therapies in clinical practice and cannot be assumed to apply to the use of these interventions in the context of clinical trials. ASCO assumes no responsibility for any injury or damage to persons or property arising out of or related to any use of ASCO's guidelines, or for any errors or omissions.

Last updated: 1/15/10