Study identifier:D6070C00004
ClinicalTrials.gov identifier:NCT03381274
EudraCT identifier:N/A
CTIS identifier:N/A
A Multiarm, Open-label, Multicenter, Phase 1b/2 Study to Evaluate Novel Combination Therapies in Subjects with Previously Treated Advanced EGFRm NSCLC
Carcinoma, Non-Small-Cell Lung
Phase 1/2
No
Osimertinib, AZD4635
All
43
Interventional
18 Years - 101 Years
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Aug 2024 by MedImmune, LLC
MedImmune, LLC
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Oleclumab Dose 1 + Osimertinib Dose 1 In Part 1 (dose-escalation), participants will receive intravenous oleclumab (MEDI9447) Dose 1 every 2 weeks (Q2W) and oral osimertinib Dose 1 once daily (QD). | Biological/Vaccine: Oleclumab Participants will receive oleclumab in combination with osimertinib or AZD4635 as stated in the arms' description. Other Name: MEDI9447 Drug: Osimertinib Participants will receive osimertinib in combination with oleclumab as stated in the arms' description. Other Name: Tagrisso® |
Experimental: Oleclumab Dose 2 + Osimertinib Dose 1 In Part 1 (dose-escalation), participants will receive intravenous oleclumab Dose 2 Q2W and oral osimertinib Dose 1 QD. In Part 2 (dose-expansion), participants (including participants dosed at the RP2D in Part 1) will receive IV oleclumab Dose 2 Q2W and oral osimertinib Dose 1 QD until documentation of disease progression, intolerable toxicity, or development of other reason for treatment discontinuation, whichever occurs first. | Biological/Vaccine: Oleclumab Participants will receive oleclumab in combination with osimertinib or AZD4635 as stated in the arms' description. Other Name: MEDI9447 Drug: Osimertinib Participants will receive osimertinib in combination with oleclumab as stated in the arms' description. Other Name: Tagrisso® |
Experimental: Oleclumab Dose 1 + AZD4635 Dose 1 In Part 1 (dose-escalation), participants will receive intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 1 QD. | Biological/Vaccine: Oleclumab Participants will receive oleclumab in combination with osimertinib or AZD4635 as stated in the arms' description. Other Name: MEDI9447 Drug: AZD4635 Participants will receive AZD4635 in combination with oleclumab as stated in the arms' description. |
Experimental: Oleclumab Dose 1 + AZD4635 Dose 2 In Part 1 (dose-escalation), participants will receive intravenous oleclumab Dose 1 Q2W and oral AZD4635 Dose 2 QD. | Biological/Vaccine: Oleclumab Participants will receive oleclumab in combination with osimertinib or AZD4635 as stated in the arms' description. Other Name: MEDI9447 Drug: AZD4635 Participants will receive AZD4635 in combination with oleclumab as stated in the arms' description. |
Experimental: Oleclumab Dose 2 + AZD4635 Dose 2 In Part 1 (dose-escalation), participants will receive intravenous oleclumab Dose 2 Q2W and oral AZD4635 Dose 2 QD. | Biological/Vaccine: Oleclumab Participants will receive oleclumab in combination with osimertinib or AZD4635 as stated in the arms' description. Other Name: MEDI9447 Drug: AZD4635 Participants will receive AZD4635 in combination with oleclumab as stated in the arms' description. |