Lung Clinical Trials

Lung

22067- Phase 1/2 Study of PRO1184 in Patients with Locally Advanced and/or Metastatic Solid Tumors: Breast Endometrial Ovarian Lung Mesothelioma – 22067- (PRO1184-001) NCT:05579366

• Phase – 1/2
• Stage(s) – III, IV
• Line of Therapy – Patients must have received EGFR-targeted therapy and platinum-based chemotherapy unless ineligible or refused by the patient
• Investigational Drug – PRO1184
• Drug Class – FRα targetted ADC
• Mechanism of Action – folate receptor alpha (FRα) targeted antibody-drug conjugate
• Biomarker(s) – cytologically confirmed metastatic or unresectable solid malignancy including ovarian cancer (must have epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer), endometrial cancer, non-small cell lung cancer, breast cancer (hormone receptor positive, HER2-negative, and triple-negative), mesothelioma.
• Sponsor – GENMAB

23083- A Phase III, Two-Arm, Parallel, Randomized, Multi-Center, Open-Label, Global Study to Determine the Efficacy of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for First-Line Treatment of Patients with Metastatic Non-Small Cell Lung Cancer – 23083 NCT05984277

• Phase – 3
• Stage(s) – IV
• Line of Therapy – FIRST LINE OR neo, adjuvant or chemorads for advanced disease eligible if progression >12 months from the end of last therapy
• Investigational Drug – Volrustomig
• Drug Class – bispecific
• Mechanism of Action – targeting PD-1 and CTLA-4 designed to provide improved safety and efficacy over the combination of antiPD-1 and anti-CTLA4 monotherapies
• Biomarker(s) – PD-L1 <50% (TESTED BY STUDY)
• Sponsor – AstraZeneca

22322- A Global Pivotal Study in Participants with KRAS G12C-Mutant, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Comparing First-Line Treatment of LY3537982 and Pembrolizumab vs Placebo and Pembrolizumab in those with PD-L1 expression >= 50% or LY3537982 and Pembrolizumab, Pemetrexed, Platinum vs Placebo and Pembrolizumab, Pemetrexed, Platinum regardless of PD-L1 Expression – 22322-SUNRAY-01 NCT06119581

• Phase – III
• Stage(s) – III, IV
• Line of Therapy – FIRST LINE
• Investigational Drug – LY3537982
• Drug Class – Inhibitor of GTP bound KRAS 12C inhibitor

23247- Study of VUDALIMAB in Combination with Chemotherapy or Keytruda in Combination with Chemotherapy as First-line Treatment in Patients with Advanced Non-small Cell Lung Cancer (OPEN AT HORSHAM AND WYNNEWOOD ONLY) – 23247- XmAb717-06: NCT06173505
FEW SLOTS REMAINING – CALL CRA

• Phase – 1b/2
• Stage(s) – N/A
• Line of Therapy – FIRST LINE
• Investigational Drug – Vudalimab
• Drug Class – Bispecific antibody
• Mechanism of Action – simultaneously targets immune checkpoint receptors PD-1 and CTLA 4.
• Biomarker(s) – PD-L1 IHC testing documenting TPS < 49%.
• Sponsor – Xencor

23074- Phase 3 Evaluating SGN-B6A (integrin beta 6 targeted antibody) Compared with Docetaxel for Adult Subjects with Previously Treated (2+ Lines) Whose Disease Has Progressed After Treatment with Pd-[L]1 Inhibitors, Platinum-Based Chemotherapy, And/or Targeted Therapy – 23074-(SGN-B6A-002)- NCT06012435

• Phase – 3
• Stage(s) – 3
• Line of Therapy – 2+
• Investigational Drug – SGN-B6A
• Drug Class – Targeted antibody
• Mechanism of Action – A vedotin antibody Drug Conjugate directed to integrin Beta 6 for multiple carcinoma indications.
• Biomarker(s) – NA
• Sponsor – Seagen

22322- A Global Pivotal Study in Participants with KRAS G12C-Mutant, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Comparing First-Line Treatment of LY3537982 and Pembrolizumab vs Placebo and Pembrolizumab in those with PD-L1 expression >= 50% or LY3537982 and Pembrolizumab, Pemetrexed, Platinum vs Placebo and Pembrolizumab, Pemetrexed, Platinum regardless of PD-L1 Expression – 22322-SUNRAY-01 NCT06119581

• Phase – II
• Stage(s) – III, IV
• Line of Therapy – FIRST LINE
• Investigational Drug – LY3537982
• Drug Class – Inhibitor of GTP bound KRAS 12C inhibitor

21498- Avutometinib (VS-6766) in Combination with Sotorasib in Patients with KRAS G12C mutant Non-Small Cell Lung Cancer (NSCLC) – 21498-RAMP 203- VS-6766-203-NCT05074810-Verastem Inc
STAR TRIAL = 2 WEEKS TO OPEN
OPEN AT LANGHORN, HORSHAM

• Phase – II
• Stage(s) – III, IV
• Line of Therapy – 2nd, 3rd
• Investigational Drug – Avutometinib (VS-6766)
• Drug Class – MEK/RAF TKI
• Mechanism of Action – Blocks both MEK kinase activity and the ability of RAF to phosphorylate MEK.
• Biomarker(s) – KRAS G12C

21318- A PHASE I-III, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF MULTIPLE THERAPIES IN COHORTS OF PATIENTS SELECTED ACCORDING TO BIOMARKER STATUS, WITH LOCALLY ADVANCED, UNRESECTABLE, STAGE III NON-SMALL CELL LUNG CANCER (BO42777)
STAR TRIAL = 2 WEEKS TO OPEN
ONLY OPEN FOR A1 ALK POSITIVE

• Phase – I, II, III
• Stage(s) – III
• Investigational Drug – Alectinib, Entrectinib, Durvalumab, depending on biomarker status
• Drug Class – Alectinib and Entrectinib = kinase inhibitor; Durvalumab = PDL-1 Inhibitor
• Biomarker(s) – ALK+, ROS1+, RET fusion +

23170- Beamion LUNG-2: A Phase III, open-label, randomized, active-controlled, multi-centre trial evaluating orally administered zongertinib (BI 1810631) compared with standard of care as first-line treatment in patients with unresectable, locally advanced or metastatic non-squamous non-small cell lung cancer harbouring HER2 tyrosine kinase domain mutations (1479-0008)
STAR TRIAL = 2 WEEKS TO OPEN

• Phase – III
• Stage(s) – advanced/metastatic
• Investigational Drug – Zongertinib (BI 1810631)
• Drug Class – TKI
• Mechanism of Action – small molecule with potent inhibitory activity on all oncogenic HER2 mutations including the HER2 YVMA insertion allele
• Biomarker(s) – HER2 tyrosine kinase domain mutations