Criteria for Highlighting Clinical Trials As Promising

Trials are highlighted when

  • There is a pivotal Phase II or Phase III trial that is enrolling or results are expected to be presented for FDA review
  • The experimental therapy is reported to be at least as effective as Standard of Care (SoC)* chemotherapy for patients in a similar clinical situation.  Results using efficacy measures of ORR and PFS must be from at least 20 patients in a Phase II or Phase I expansion trial.
  • There is an ongoing Phase II or Phase III trial with same or similar drugs.

 

*Standard of Care chemotherapy treatments are as described in National Comprehensive Cancer Network (NCCN) guidelines (and on this website).

Standard of care efficacy metrics used in the experimental therapy comparisons were assigned based on platinum response status of the trial participants:

Platinum Sensitive (Pt-S):   ORR  60%;  PFS 10 months

Platinum Resistant (Pt-R): ORR  15%;  PFS  4 months (N.B. for combination therapies: ORR 25%, PFS 6 months)