Study of AK119 and AK112 With or Without Chemotherapy for NSCLC Patients

Lead sponsor

Akeso is the lead sponsor of 154 studies on the registry; 67 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Study arms

• Experimental
  AK119 + AK112

  Subjects will receive AK119 plus AK112 via intravenously (IV) Q3W, up to 2 years.

  Drug: AK119 · Drug: AK112

• Experimental
  AK119 + AK112 + Pemetrexed + Carboplatin

  Subjects will receive AK119 and AK112 plus pemetrexed and carboplatin via intravenously (IV) Q3W, up to 4 cycles. Afterward, AK119 and AK112 plus pemetrexed will continue to be treated up to 2 years.

  Drug: AK119 · Drug: AK112 · Drug: Pemetrexed · Drug: Carboplatin

• Experimental
  AK112

  Subjects will receive AK112 monotherapy via intravenously (IV) Q3W, up to 2 years.

  Drug: AK112

Interventions

• DrugAK119

  AK119 IV every 3 weeks.

• DrugAK112

  AK112 IV every 3 weeks.

• DrugPemetrexed

  Pemetrexed IV every 3 weeks.

• DrugCarboplatin

  Carboplatin IV every 3 weeks.

Primary outcomes

1. Number of subjects with dose limiting toxicities (DLTs)

   DLTs will be assessed during the first 3 weeks of treatment. DLTs are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the DLT observation period.

   Time frame: During the first 3 weeks

2. Number of subjects with adverse events (AEs)

   AE refers to any untoward medical occurrence or deterioration of existing medical event after the subject signed the ICF, whether or not considered related to the study treatment.

   Time frame: From the time of informed consent signed through 90 days after the last dose of study drug

3. Objective response rate (ORR)

   ORR is defined as the proportion of subjects with confirmed CR or confirmed PR.

   Time frame: Up to 2 years

Secondary outcomes

1. Progression-free survival (PFS)

   PFS is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first (based on RECIST Version 1.1).

   Time frame: Up to 2 years

2. Disease control rate (DCR)

   DCR is defined as the proportion of subjects with CR, PR, or SD (based on RECIST Version 1.1).

   Time frame: Up to 2 years

3. Duration of response (DoR)

   DoR is defined as the duration from the first documentation of objective response to the first documented disease progression (based on RECIST Version 1.1) or death due to any cause, whichever occurs first.

   Time frame: Up to 2 years

4. Time to response (TTR)

   TTR is defined as the time from the start of the treatment to the first objective tumor response observed for patients who achieved CR or PR (based on RECIST Version 1.1).

   Time frame: Up to 2 years

5. Overall survival (OS)

   OS defined as the time from the first dose to death from any cause.

   Time frame: Up to 2 years

6. Maximum observed concentration (Cmax) of AK119 and AK112

   The PK parameters include serum concentrations of AK119 and AK112 at different timepoints after study drug administration.

   Time frame: From first dose of study drug through last dose

7. Number of subjects who develop detectable anti-drug antibodies (ADAs)

   The immunogenicity of AK119 and AK112 will be assessed by summarizing the number of subjects who develop detectable antidrug antibodies (ADAs).

   Time frame: From first dose of study drug through last dose