Squamous Non Small Cell Lung Cancer Clinical Trial
Official title:
A Phase 2a, Multi-centre, Single-arm Trial of the Combination of AZD2014 and Weekly Paclitaxel in Patients With Relapsed or Refractory Squamous Non-Small Cell Lung Cancer After At Least One Line of Prior Therapy
Open--label, phase 2a, multi-centre, single-arm study to assess the efficacy and safety of AZD2014 and weekly paclitaxel in patients with squamous non-small cell lung cancer (NSCLC)
This is an open-label, phase 2a, multi-centre, single-arm study to assess the efficacy and
safety of the combination of AZD2014 and weekly paclitaxel in patients with squamous
non-small cell lung cancer (NSCLC) that is relapsed or refractory to conventional treatment
after at least 1 prior treatment with standard of care (SOC) and for whom weekly paclitaxel
treatment is an appropriate treatment choice.
The study will simultaneously enrol patients to the following two groups. Group A (intensive
PK) will enrol 10 evaluable patients for an intra-patient evaluation of the impact of
paclitaxel on exposure to AZD2014, and the impact of AZD2014 on exposure to paclitaxel via
intensive PK sampling and non-compartmental PK analysis techniques (NCA). Group B (sparse PK)
will enrol 30 patients and sparse sampling and population PK modelling techniques will be
employed to estimate exposure to AZD2014 when administered in combination with a weekly
paclitaxel dosing regimen. The efficacy and safety of the AZD2014 and weekly paclitaxel
combination will be evaluated in all 40 patients using RECIST 1.1, observation of AEs/SAEs
and use of conventional safety parameters.
Eligible patients will receive study treatment consisting of a single weekly paclitaxel
infusion (80 mg/m2) on Day 1 of each week and twice daily (BD) 50 mg doses of AZD2014 on the
first 3 days each week for 6 weeks [except Group A patients in Week 1 of Cycle 1 who will
take 50 mg BD doses of AZD2014 on Days 3, 4 and 5 (or Days 4, 5 and 6) to accommodate PK
sampling], followed by a break from treatment when no paclitaxel or AZD2014 will be given.
This 7-week schedule composes one cycle of treatment. AZD2014 will be administered as oral
tablets to fasted patients (i.e., no food 2 hours before and 1 hour after each dose).
Patients will receive up to 6 cycles of paclitaxel, although additional cycles of paclitaxel
may be given if deemed appropriate by the Investigator.
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