A Study of IMC-A12 (Cixutumumab) With and Without Other Standard Chemotherapies in Participants With Lung Cancer Who Have Not Received Chemotherapy Before

Browse trials for

• Carcinoma, Non-Small-Cell Lung 6,641
• Neoplasms 9,610

Keywords

• Tumors
• Antibodies, Monoclonal
• Stage IIIb Metastatic Non-Small Cell Lung Cancer
• Stage IV Metastatic Non-Small Cell Lung Cancer

Carcinoma, Non-Small-Cell Lung

6,641 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,665 are open to participants now.

This study's enrollment of 64 is close to the median of 62 across 5,327 interventional studies indexed under Carcinoma, Non-Small-Cell Lung.

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,095 studies on the registry; 142 are open to participants now.

Of its 535 completed or terminated interventional studies of FDA-regulated products, 356 (67%) have results posted.

Study arms

• Experimental
  GCiC + IMC-A12 (Gemcitabine/Cisplatin/Cetuximab + Cixutumumab)

  Cycles repeat every 3 weeks for first 6 cycles (18 weeks) and then once every 2 weeks (maintenance therapy) until disease progression, intolerable toxicity, withdrawal of consent or other withdrawal criteria met \*Cisplatin will replace Carboplatin. Gemcitabine/Carboplatin/Cetuximab (GCC) plus cixutumumab will change to Gemcitabine/Cisplatin/Cetuximab (GCiC) plus cixutumumab (participants enrolled subsequent to this change will receive gemcitabine, cisplatin and cetuximab, plus cixutumumab)

  Drug: Gemcitabine · Drug: Cisplatin · Biological: IMC-A12 (cixutumumab) · Biological: Cetuximab · Drug: Carboplatin

• Active comparator
  GCiC (Gemcitabine/Cisplatin/Cetuximab)

  Cycles repeat every 3 weeks for 6 cycles (18 weeks) and then once every 2 weeks (maintenance therapy) until disease progression, intolerable toxicity, withdrawal of consent or other withdrawal criteria met \*Cisplatin will replace Carboplatin. GCC plus cixutumumab will change to GCiC plus cixutumumab (participants enrolled subsequent to this change will receive gemcitabine, cisplatin and cetuximab, plus cixutumumab)

  Drug: Gemcitabine · Drug: Cisplatin · Biological: Cetuximab · Drug: Carboplatin

Interventions

• DrugGemcitabine

  1000 milligrams per square meter (mg/m\^2) on Days 1 and 8 of each cycle \[First 6 cycles (18 weeks)\]

• DrugCisplatin

  75 mg/m\^2 on Day 1 of each cycle \[First 6 cycles (18 weeks)\]

• BiologicalIMC-A12 (cixutumumab)

  6 milligrams per kilogram (mg/kg) intravenous (IV) infusion, administered once per week (on Days 1, 8, and 15 of each cycle) \[First 6 cycles (18 weeks)\]

  Also known as: Cixutumumab, LY3012217

• BiologicalCetuximab

  400 mg/m\^2 IV infusion, administered on Day 1 of Cycle 1, 250 mg/m\^2 once per week thereafter \[First 6 cycles (18 weeks)\]

  Also known as: Erbitux®

• BiologicalIMC-A12 (cixutumumab)

  10 mg/kg IV infusion, administered once every 2 weeks (Maintenance therapy)

  Also known as: Cixutumumab, LY3012217

• BiologicalCetuximab

  500 mg/m\^2 IV infusion, administered once every 2 weeks (Maintenance therapy)

  Also known as: Erbitux®

• DrugCarboplatin

  Area under the curve (AUC) = 5, Day 1 of each cycle \[First 6 cycles (18 weeks)\] \*Carboplatin will be replaced by Cisplatin

Primary outcomes

1. Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]

   ORR was defined as the percentage of participants achieving either CR or PR. Response was defined using Response Evaluation Criteria in Solid Tumors (RECIST), version (v) 1.0 criteria. CR was defined as the disappearance of all target and non-target lesions and the normalization of the tumour marker level. PR was defined as having at least a 30% decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Percentage of participants is calculated as a total number of participants with CR or PR / total number of participants treated \* 100.

   Time frame: Randomization to measured progressive disease (PD) (up to 16.9 months)

Secondary outcomes

1. Overall Survival (OS)

   OS was defined as the duration from the date of randomization to the date of death from any cause. For participants who were alive, OS was censored at the date of last follow-up visit or at the date of last contact.

   Time frame: Randomization to death due to any cause or censor (up to 30.4 months)

2. Progression-Free Survival (PFS)

   PFS was defined as the duration from the date of randomization until disease progression or death due to any cause, whichever occurred first. Response was defined using RECIST, v 1.0 criteria. PD was defined as having a ≥20% increase in sum of LD of target lesions or the appearance of new lesions and/or unequivocal progression of non-target lesions. For participants who were alive and without disease progression, PFS was censored at the date of last objective tumor assessment. For participants who did not experience disease progression and were lost to follow-up, PFS was censored at the date of the last objective tumor assessment or the date of last contact.

   Time frame: Randomization to PD or death due to any cause or censor (up to 16.9 months)

3. Time To Progression (TTP)

   TTP was defined as the duration from the date of randomization until the date of disease progression. Response was defined using RECIST v 1.0 criteria. PD was defined as having a ≥20% increase in the sum of LD of target lesions or the appearance of new lesions and/or unequivocal progression of non-target lesions. For participants without disease progression, TTP was censored at the date of last objective tumor assessment. For participants without disease progression and were subsequently lost to follow-up, TTP was censored at the date of last follow-up visit or at the date of last contact.

   Time frame: Randomization to months until PD or censor (up to 16.9 months)

4. Duration of Response

   The duration of CR or PR was defined as the time from first objective status assessment of CR or PR to the first time of disease progression or death. Response was defined using RECIST v 1.0 criteria. CR was defined as the disappearance of all target lesions and non-target lesions. PR was defined as having at least a 30% decrease in sum of LD of target lesions. Duration of response was censored on the date of last tumor assessment for participants who were alive and have no evidence of disease progression.

   Time frame: Date of first response to the date of PD or death due to any cause or censor ( up to 15.5 months)

5. Number of Participants With Adverse Events (AEs) or Deaths

   Data presented are the number of participants who experienced 1 or more AEs, serious AEs (SAEs), and AEs that lead to death during the study including the 30-day follow-up. A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this report.

   Time frame: Randomization to last dose of study medication (up to 11.7 months) plus 30-day safety follow-up

6. Serum Anti-Cixutumumab Antibody Assessment (Immunogenicity)

   Time frame: Prior to first infusions of Cycles 1, 3, and 5 and 30 days following the end of therapy

7. Maximum Concentration (Cmax) of Cixutumumab at Study Day 1

   Time frame: Day 1

8. Cmax of Cixutumumab for Cycle 1

   Time frame: Week 1 (Cycle 1, Day 1)

9. Cmax of Cixutumumab for Cycle 3

   Time frame: Week 7 (Cycle 3, Day 1)

10. Cmax of Cixutumumab Cycle 5

    Time frame: Week 13 (Cycle 5, Day 1)

11. Minimum Concentration (Cmin) of Cixutumumab at Study Day 1

    Time frame: Day 1

12. Cmin of Cixutumumab for Cycle 1

    Time frame: Week 1 (Cycle 1, Day 1)

13. Cmin of Cixutumumab for Cycle 3

    Time frame: Week 7 (Cycle 3, Day 1)

14. Cmin of Cixutumumab for Cycle 5

    Time frame: Week 13 (Cycle 5, Day 1)

Baseline characteristics

2 further baseline measures are reported on the registry.