Phase II clinical trial - Appareil pulmonaire

SAVANNAH (D5084C00007)
Appareil pulmonaire
Ouvert depuis le: 12.08.2021
Site: Paris
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Phase II, Single Arm Study Assessing the Efficacy of Osimertinib in;Combination with Savolitinib in Patients with EGFRm+ and MET+, Locally;Advanced or Metastatic Non-Small Cell Lung Cancer who have Progressed;Following Treatment with Osimertinib (The SAVANNAH Study)
Description de l'essai

All patients will be assigned to 300 mg od savolitinib flat dosing (see Figure 1) replacing;the previous weight-based dosing regimen where patients were assigned to either 300mg od;or 600 mg od savolitinib dependent upon their weight at Screening. Rationale for this;change is described in sections 1.2, 2, 2.1, 4.3 and in a revised study design schema in;section 1.3 Figure 1, and revised layout of Table 7 showing savolitinib dose reductions.;Preliminary review of emerging clinical data from the Phase I TATTON study carried out;by the Sponsor indicated that there was an improvement in overall safety profile with no;apparent reduction in objective response rate between weight-based savolitinib dosing;(TATTON Part B) and 300 mg dose (TATTON Part D) in combination with osimertinib;80mg QD. Patients who commenced study treatment at 600 mg savolitinib can choose to;either continue at this dose or change to 300 mg (no subsequent re-escalation will be;permitted after changing to 300 mg dose).