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Lung Cancer Research Priorities Established


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Lung Cancer Research Priorities Established


The Coalition’s SLC in Lung Cancer unveiled research priorities in May 2006 at a milestone public forum, Joining Forces Against Lung Cancer. The forum brought together a wide variety of stakeholders—community and academic providers, surgical specialists, state and professional medical societies, industry, and 20 patient advocate organizations—concerned with inadequate early-stage screening and diagnosis, the lack of early-stage cancer clinical trials, the low rates of accrual into lung cancer clinical trials, and the need to close the gap that keeps patients from benefiting from new treatment approaches. More than 70% of lung cancer patients are diagnosed in late stages, and 60% die within 1 year, leaving few patients to accrue into trials. Only 14% of lung cancer patients are aware of cancer clinical trials at the time of diagnosis, and only 1% of lung cancer patients are enrolled in cancer clinical trials each year. Speakers noted that lung cancer patient enrollment has actually declined over the past 5 years. This meeting focused attention on closing the gap between patients and emerging early-stage therapies that are showing promise in improving survival. Speakers cited new data from 6 major trials showing that adjuvant therapy could increase survival rates for patients with stage IB to IIIA NSCLC from 40%

to 55%. The 2006 SLC in Lung Cancer forum was supported by Amgen, Genentech, Novartis, OSI, and sanofi-aventis. The SLC in Lung Cancer has identified 4 high-priority trials, which will require more than 3000 patients and an active recruitment effort in 2007.

Neoadjuvant (initial) TherapyTrial: UPCI 04-094Patient population: Stages IB, II, IIIA, (N2Negative) NSCLCDescription: Randomized phase 3 trial of chemotherapy either after (adjuvant) or before (neodjuvant) primary surgery for patients with early stage NSCLC Projected enrollment: 370 patientsSponsor: University of Pittsburgh Cancer InstituteProtocol chair: Chandra P. Belani, MD, PI, 412-648-6619; belanicp@upmc.edu

Surgical Adjuvant (therapy

following surgery)Trial: RADIANT (Randomized double-blind trial in adjuvant NSCLC with erlotinib [Tarceva®])Protocol ID: OSI-774-302 Patient population: Stage IB-IIIA NSCLCDescription: Complete surgical resection with or without adjuvant chemotherapy in patients with stage IB-IIIA NSCLC who have epidermal growth factor receptor (EGFR)-positive tumors; patients will be randomized (2:1) based on biologic features (patients must have EGFR-positive tumor tissue by immunohistochemistry [iHC] and/or fluorescence in situ hybridization [FISH]) to receive either erlotinib or placeboProjected enrollment: Approximately 975 patients (1730 patients will be screened for EGFR)Sponsor: OSIContact: OSI Medical Affairs, 303-546-7821; medical-information@osip.com

Trial: E1505 (planned)Patient population: Stage IB-IIIA NSCLCDescription: Chemotherapy with or without bevacizumab (Avastin®) in patients with stage IB-IIIA NSCLC that was removed by surgeryProjected enrollment: 1500 patientsSponsor: ECOG Protocol chair: Heather Wakelee, MD, 650-723-9094; hwakelee@stanford.edu

Locally Advanced DiseaseTrial: S0533Patient population: Stage III NSCLCDescription: Phase 1/Phase 2 pilot study of induction therapy comprising cisplatin, etoposide, and radiotherapy with or without bevacizumab (Avastin) followed by consolidation therapy comprising docetaxel and bevacizumab in patients with newly diagnosed, unresectable, stage III NSCLCProjected enrollment: 168 (2 strata and 3 cohorts)Sponsor: SWOGProtocol chair: Antoinette Wozniak, MD, 313-576-8752 or 800-527-6266; wozniakt@karmanos.org

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