Ebru Karcı

International publications

• Studies on first-line treatment for metastatic non-small cell lung cancer (NSCLC).
• Phase III randomized trials of small cell lung cancer (SCLC)
• ER positive / HER2 negative advanced-stage breast cancer studies
• Triple-negative breast cancer (ASCENT-03, ASCENT-04) studies
• KRAS G12C mutation related NSCLC studies
• EGFR mutation-related lung cancer studies
• Endometrial cancer and urothelial cancer phase III studies
• Immunotherapy combination therapies (Pembrolizumab, Durvalumab, Atezolizumab, Tiragolumab, etc.)

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Clinical Trials

• TransCelerate V6.0 ICH E6 (R3)
• Randomized, double-blind, phase 3 study of platinum-based chemotherapy with or without INCMGA00012 in first-line metastatic squamous and non-squamous non-small cell lung cancer (2020-Allied Investigator)
• Phase III, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Atezolizumab Plus Carboplatin and Etoposide with or without Tiragolumab (Anti-TIGIT Antibody) in Patients with Untreated Extensive Small Cell Lung Cancer (GO41767) (202003016) (2020-Associate Investigator)
• Randomized, multicenter, double-blind phase 3 study comparing letrozole plus palbociclib with SAR439859 plus palbociclib treatment in patients with advanced ER (+), HER2 (-) breast cancer who have not received systemic anti-cancer therapy – AMEERA-5, EFC15935” and “EFC15935 (Ministry code: 202003120)” (2021-Assistant Investigator)
• “Phase 3 Randomized Study Comparing Combination Amivantamab and Lazertinib as First-Line Therapy with Osimertinib Alone and Lazertinib Alone in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer with EGFR Mutation” and “73841937NSC3003 (Ministry code: 202003090) (2021-Assistant Investigator)”
• Randomized, open-label Phase 3 Study comparing combination therapy of amivantamab and carboplatin pemetrexet with carboplatin pemetrexet therapy alone in patients with locally advanced or metastatic non-small cell lung cancer with EGFR exon 20ins mutation” and “61186372NSC3001 (Ministry code: 202003118) (2021-Assistant Investigator)
• Phase III, open-label, randomized trial comparing atezolizumab and tiragolumab with durvalumab in patients with locally advanced, unresectable stage III non-small cell lung cancer that has not progressed after concomitant platinum-based chemoradiation (Skyscraper-03), GO41854, SKYSCAPER03 (2020-Associate Investigator)
• A phase III, randomized, double-blind, placebo-controlled study evaluating atezolizumab plus carboplatin and etoposide with or without tiragolumab (anti-tigit antibody) in patients with untreated extensive small cell lung cancer, GO41767 SKYSCRAPER02 (2020-Associate Investigator)
• Comparison of Concurrent Chemoradiation Therapy Alone with Combination Chemoradiation Therapy in Volunteers with Newly Diagnosed, Previously Untreated, Limited Stage Small Cell Lung Cancer (SESCLC) (2020-Associate Investigator)
• Randomized, double-blind, placebo-controlled, phase 3 study of pembrolizumab (MK-3475) followed by olaparib (MK7339) or without olaparib” and “MK7339-013 (Ministry code: 202003108)
• A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study Evaluating the Efficacy and Safety of a Combination of Gdc9545 and Palbociclib Compared to a Combination of Letrozole and Palbociclib in Patients with Estrogen Receptor-Positive, Her2-Negative Locally Advanced or Metastatic Breast Cancer, BO41843, PersevERA (2020-Associate Investigator)
• “A Phase III, Randomized, Multicenter, Double-Blind, Placebo-Controlled Study to Determine the Efficacy of Adjuvant Durvalumab in Combination with Platinum-Based Chemotherapy in Fully Resected Stage II-III Non-Small Cell Lung Cancer (MeRmaiD-1)” and “D910LC00001(Mermaid-1) (Ministry code: 202003050) (2020-Assistant Investigator)”
• Phase 3 Randomized, Double-Blind Study of Pembrolizumab in Combination with Adjuvant Chemotherapy vs. Placebo, with or without Radiotherapy, for the Treatment of Newly Diagnosed High-Risk Endometrial Cancer After Curative Surgery (KEYNOTE-B21 / ENGOT-en11 / GOG-3053)” and “MK3475-B21 (Ministry code: 202003126) (2020-Associate Investigator)
• PIK3CA Registry Study: A descriptive study on PIK3CA mutations in patients with HR+/Her2- advanced breast cancer” and “CBYL719C2401 (Ministry code: – ) (2020-Assistant Researcher)
• “Randomized, Controlled, Multicenter, 3-Arm Phase III Study Investigating Neoadjuvant Osimertib Monotherapy or Chemotherapy in Combination with Standard Chemotherapy vs. Standard Chemotherapy in Resectable Non-Small Cell Lung Cancer Patients with Epidermal Growth Factor Receptor Mutation Positive (NeoADAURA)” and “D516AC00001(NeoADAURA) (Ministry code: 202003046) (2020-Assistant Investigator)”
• Phase 3 Study of Pembrolizumab (MK-3475) in Combination with Olaparib or Pembrolizumab (MK-3475) Compared to Durvalumab Following Concurrent Chemoradiotherapy in Volunteers with Unresectable, Locally Advanced Stage III Non-Small Cell Lung Cancer (NSCLC)” and “MK7339-012 (Ministry code: 2020030119)” (2020-Assistant Investigator)
• “Phase 3 Randomized Study Comparing Combination Amivantamab and Lazertinib as First-Line Therapy with Osimertinib Alone and Lazertinib Alone in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer with EGFR Mutation” and “73841937NSC3003 (Ministry code: 202003090) (2020-Assistant Investigator)”
• Durvalumab in patients with minimal residual disease after surgical and therapeutic treatment of Stage II/III NSCLC (2020-Associate Investigator)
• Phase III randomized, multicenter, double-blind, placebo-controlled trial of the treatment of patients (Mermarid 2) D910MC00001
• International Durvalumab trial with Stereotactic Body Radiation Therapy (SBRT) for the treatment of unresected Stage I/II, lymph node-negative non-small cell lung cancer patients, double-blind, placebo, (PASIFIC 4) Phase III randomized trial. (Code D9103C00001) (2020-Associate Investigator)
• MK-7684A Open Label Phase 3 Study (Vibostolimab Co-Formulation with Pembrolizumab) Concomitant Chemoradiotherapy followed by MK 7684A vs. Concomitant Chemoradiotherapy followed by Durvalumab in Combination of Unresectable, Locally Advanced, Stage III NSCLC (mk7684A-006 MSD) (2022-Associate Investigator)
• Randomized, double-blind, phase 3 study evaluating MK-7684A (vibostolimab and pembrolizumab coformulation) and MK-7684A alone followed by combination of etoposide and platinum as first-line treatment in volunteers with extensive stage small cell lung cancer” and “MK7684A-008 (Ministry code: 202203033) (2022-Associate Investigator)”
• Randomized, open-label Phase 3 trial (EMBER-3) comparing LY3484356 with investigator’s choice of endocrine therapy in patients with estrogen receptor-positive, HER2-negative locally advanced or metastatic breast cancer who previously received endocrine therapy (Ministry code: 202108086) (2022-Associate Investigator)
• Study investigating *Sacituzumab Govitecan versus physician-choice treatment in patients with previously untreated, locally advanced, inoperable, or metastatic triple-negative breast cancer whose tumors do not express PD-L1, or in patients previously treated with early-stage anti-PD-(L)1 agents whose tumors do express PD-L1 (ASCENT-03) (2023-Associate Investigator)
• Physician-Choosed Treatment and *Pembrolizumab vs. Sacituzumab Govitecan and Pembrolizumab Study in Patients with Previously Untreated, Locally Advanced, Inoperable or Meastatic, Triple-Negative Breast Cancer with Tumors Expressing PD-L1 (ASCENT-04) (2023-Associate Investigator)
• Study investigating BI 907828 versus doxorubicin as primary-line treatment for patients with advanced dedifferentiated liposarcoma (Brighline-1) (2023-Associate Investigator)
• KontRASt-06: An open-label phase II study evaluating the activity and safety of the single agent JDQ443 as first-line therapy in patients with locally advanced or metastatic non-small cell lung cancer with KRAS G12C mutations, either with PD-L1 expression <1% or with PD-L1 expression ≥1% and STK11 co-mutation. no: CJDQ443B1220 (2023-Allied Investigator)
• Open-label, randomized, phase 3 study comparing tarlatamab to standard therapy after platinum-based first-line chemotherapy in volunteers with relapsed small cell lung cancer (DeLLphi-304) (2023-Associate Investigator)
• Phase II, Open-Label Study of Sacituzumab Govitecan vs. Platinum-Based Dual Chemotherapy in Locally Advanced/Metastatic Non-Small Cell Lung Cancer with Disease Progression After Treatment with Osimertinib in Resectable, Locally Advanced/Metastatic Urothelial Cancer, and EGFR Mutant Volunteers with Detected MET-Overexpression and/or Amplification (SAFFROn) (2023-Associate Investigator)
• “A Phase 3, Multicenter, Randomized, Open-Label Study Evaluating the Efficacy of Sotorasib Platinum Double Combination Compared to Pembrolizumab Platinum Double Combination as First-Line Therapy in Volunteers with Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell, PD-L1 Negative and KRAS p.G12C Positive Lung Cancer (CodeBreaK 202)” “(20190341) (2024-Associate Investigator)
• Multicenter, randomized, double-blind, phase 2 basket study (mk4280A-010) evaluating MK-4280A, a coformulation of favezelimab (MK-4280) and pembrolizumab (MK-3475), in selected solid tumors (2024-Associate Investigator)
• MK2870-007 (2024-Associate Investigator) is a randomized, open-label, phase 3 study evaluating MK-2870 in combination with pembrolizumab as first-line treatment in volunteers with metastatic non-small cell lung cancer with a PD-L1 tumor proportion score greater than or equal to 50%.
• First-line treatment of patients with metastatic non-small cell lung cancer or anaplastic lymphoma kinase genomic tumor abnormalities (STAR-121) (2023-Associate Investigator)
• A phase 3 study evaluating zimberelimab (ab122) monotherapy, Frontline, pd-l1-positive, advanced or metastatic non-small cell lung cancer (arc-10) in combination with local ab154 or standard chemotherapy (ARC-10) (2021-Contributory Investigator)
• Study investigating *sacituzumab govitecan in response to physician-selected treatment in patients with previously untreated, locally advanced, inoperable or metastatic triple-negative breast cancer whose tumors do not express PD-I1, or in patients who have been previously treated with early-stage anti-PD-(I)1 agents and whose tumors do express PD-I1 (ascent-03) (2023-Associate Investigator)
• Study investigating physician-choice treatment and *pembrolizumab versus sacituzumab govitecan and pembrolizumab in patients with previously untreated, locally advanced, inoperable or meastatic, triple-negative breast cancer with PD-L1 expressing tumors (ASCENT-04) (2023-Associate Investigator)
• “G1T28-211” (2024-Associate Investigator) is a randomized, double-blind, placebo-controlled, second or third-line study comparing Trilaciclib in combination with Topotecan Chemotherapy and Placebo in patients with advanced stage small cell lung cancer (ES-SCLC) who have progressed after first-line platinum-based chemotherapy.
• Interventional, open-label, randomized, multicenter, phase III (2024-Associate investigator) of PF-07220060 plus fulvestrant compared to investigator’s choice in participants over 18 years of age with HR-positive, HER2-negative, advanced/metastatic breast cancer and disease progression after previous CDK 4/6 inhibitor-based therapy.