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Motexafin gadolinium

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1 dose of MGd 15 mg/kg and pemetrexed 500 mg/m2 once during the first week of every 3-week treatment cycle for a maximum of 12 cycles

Motexafin gadolinium and pemetrexed

Martin Edelman, MD

The goals of this study are:

* to determine if the combination of two drugs, motexafin gadolinium and pemetrexed, may be an effective treatment for patients with non-small cell lung cancer (NSCLC) who have had one previous chemotherapy regimen that included a platinum containing drug such as cisplatin or carboplatin.
* to assess response to treatment in patients with NSCLC six months after beginning study treatment.

Trial of Motexafin Gadolinium and Pemetrexed (Alimta®) for Second Line Treatment in Patients With Non-Small Cell Lung Cancer

Phase II Trial of Motexafin Gadolinium and Pemetrexed (Alimta®) for Second Line Treatment in Patients With Non-Small Cell Lung Cancer

proportion of patients who are still alive and who have not progressed clinically or radiographically 6 months after receiving their first dose of MGd.

Time to progression is defined as the time from first dose of MGd to first evidence of progression.

Patient population for this endpoint consists of all patients receiving at least 1 dose of MGd and pemetrexed.

Progression-free survival is defined as the time from first dose MGd to the earlier of progression or death.

Patient population for this endpoint consists of all patients receiving at least 1 dose of MGd and pemetrexed and underwent at least response assessment.

Duration of response (CR + PR) is defined as the time from first response to the time of disease progression.

Patient population for this endpoint consists of all patients receiving at least 1 dose of MGd and pemetrexed and underwent at least response assessment

All patients who receive any MGd will be included in the safety summaries and analyses

Pharmacyclics LLC.

Amino Acids

Erlotinib Hydrochloride

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Tyrosine

Placebo infusion every 3 weeks and oral erlotinib 150 mg/day

Infusion of Patritumab (loading dose of 18 mg/kg, followed by 9 mg/kg every 3 weeks) and oral erlotinib 150 mg/day

Infusion of Patritumab (loading dose of 18 mg/kg, followed by 9 mg/kg every 3 weeks)

Patritumab

Erlotinib

Placebo

Global Clinical Leader

1. Part A: Subjects will receive Patritumab or placebo with erlotinib. Progression-free survival will be the primary outcome. Subjects will need to have Epidermal Growth Factor Receptor (EGFR) wild-type, locally advance or metastatic NSCLC and have their cancer progressed after at least one prior systemic anti-cancer therapy, available recent or archival tumor specimen and may not have had previous EGFR-targeted regimen, anti-HER2 (Human Epidermal Growth Factor Receptor 2), anti-HER3, or anti-HER4 therapy. Subjects may have high heregulin or low heregulin.
2. Part B: Subjects will receive Patritumab or placebo with erlotinib. Overall survival will be the primary outcome. Subjects will need to have EGFR wild-type, locally advance or metastatic NSCLC and have their cancer progressed after at least one prior systemic anti-cancer therapy, available recent or archival tumor specimen and may not have had previous EGFR-targeted regimen, anti-HER2, anti-HER3, or anti-HER4 therapy. Only subjects with high heregulin will be enrolled.

Study of Patritumab in Combination With Erlotinib in Subjects With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC). (HER3-Lung)

Phase 3, Randomized, Placebo-Controlled, Double-Blind, Multi-Center, Two-Part Study of Patritumab (U3-1287) In Combination With Erlotinib in EGFR Wild-type Subjects With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) Who Have Progressed on at Least One Prior Systemic Therapy

PFS is defined as the time from the date of randomization to the earlier of the dates of first objective documentation of radiographic disease progression (as per RECIST Version 1.1 per investigator assessment) or death resulting from any cause.

Kaplan-Meier Estimate. Confidence interval (CI) for median was computed using the Brookmeyer-Crowley method. 80% confidence interval is included in the data table.

Percentage of participants still alive at the end of Part B

Key secondary efficacy endpoint: Percentage of participants who survived for the length of the trial

PFS is defined as the time from the date of randomization to the earlier of the dates of first objective documentation of radiographic disease progression (TTD, as per RECIST Version 1.1 per investigator assessment) or death resulting from any cause.

Key secondary efficacy endpoint: Objective response is defined as percentage of participants achieving complete response (CR) or partial response (PR)

Denominator for percentages is the number of subjects with measurable disease in the full analysis set. The best overall response is the best response \[in the order of CR, PR, stable disease (SD), and progressive disease (PD)\] among all overall responses recorded from the start of treatment until the subject withdraws from the study. If there is no post-baseline tumor assessment or all post-baseline tumor assessments with overall response being Inevaluable captured in the CRF, the best overall response is classified as Inevaluable.

Key secondary efficacy endpoint: Objective response is defined as percentage of participants achieving complete response or partial response

Denominator for percentages is the number of subjects with measurable disease in the full analysis set. The best overall response is the best response (in the order of CR, PR, SD, and PD) among all overall responses recorded from the start of treatment until the subject withdraws from the study. If there is no post-baseline tumor assessment or all post-baseline tumor assessments with overall response being Inevaluable captured in the CRF, the best overall response is classified as Inevaluable.

Parexel

Daiichi Sankyo

Treatment emergent (TE) adverse events (AEs) are reported for patritumab only. If relatedness is missing, the AE is counted as related to patritumab.

Placebo + Erlotinib

Patritumab + Erlotinib

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Histology subtype

Histology subtype (for randomization)

Eastern Cooperative Oncology Group (ECOG) Score

Heregulin (HRG) expression from Interactive Web/Voice Response System (IXRS)

Part A: Progression Free Survival (PFS) in Heregulin-high Participants

Part A: Progression Free Survival (PFS) in Heregulin-low Participants

No participants were analyzed for Part B endpoints because the trial was terminated at the end of Part A.

Part B: Overall Survival

Part A: Overall Survival in HRG High Participants

Part A: Key Secondary Efficacy Endpoint: Overall Survival in HRG Low Participants

Part B: Key Secondary Efficacy Endpoint: PFS, TTD

Evaluable participants in the full analysis set

Part A: Objective Response Rate (ORR) in HRG High Participants

Part A: Objective Response Rate (ORR) in HRG Low Participants

Overall Study

Docetaxel

Cisplatin

Motexafin Gadolinium Injection

The purpose of the study is to determine the dose limiting toxicities and maximum tolerated dose of motexafin gadolinium when administered with docetaxel and cisplatin in patients with Non-small Cell Lung Cancer.

A cycle consists of 3 weeks. During week 1, patients receive MGd, docetaxel, and cisplatin treatment followed by 2 weeks without treatment.

Eligible patients will receive 1 or 2 doses of MGd, depending on cohort, and a single dose of docetaxel and cisplatin at 75 mg/m² during the first week of each cycle. Additionally, tumor response will be evaluated at the end of even numbered cycles (2, 4, and 6). Patients may stay on the study a maximum of 6 cycles.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Trial of Motexafin Gadolinium and Pemetrexed (Alimta®) for Second Line Treatment in Patients With Non-Small Cell Lung Cancer	NCT00365183	Non-Small Cell ...	Motexafin gadol...	18 Years -	Pharmacyclics LLC.
Trial of Motexafin Gadolinium and Pemetrexed (Alimta®) for Second Line Treatment in Patients With Non-Small Cell Lung Cancer	NCT00365183	Non-Small Cell ...	Motexafin gadol...	18 Years -	Pharmacyclics LLC.
Study of Patritumab in Combination With Erlotinib in Subjects With Locally Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC). (HER3-Lung)	NCT02134015	Lung Cancer Non-small Cell ...	Patritumab Erlotinib Placebo	20 Years -	Daiichi Sankyo
A Study of Motexafin Gadolinium (MGd) in Combination With Docetaxel and Cisplatin for Treatment of Non-Small Cell Lung Cancer (NSCLC)	NCT00102505	Non-Small-Cell ... Carcinoma, Bron...	Motexafin Gadol...	18 Years -	Pharmacyclics LLC.

Spots Global Cancer Trial Database for bronchogenic

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