Phase 2
N=82
Rovalpituzumab Tesirine (SC16LD6.5) in Recurrent Small Cell Lung Cancer
Recurrent Small Cell Lung Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01901653 ↗Enrolled (actual)
82
Serious AEs
40.2%
Results posted
Jul 2018
Primary outcome: Primary: Maximum Tolerated Dose (MTD) of Rovalpituzumab Tesirine — 0.4 mg/kg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Rovalpituzumab tesirine (SC16LD6.5) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Stemcentrx
- Primary completion
- Nov 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Tolerated Dose (MTD) of Rovalpituzumab Tesirine |
0.4 | — |
| SECONDARY Objective Response Rate (ORR) |
25; 0; 17; 0; 27; 0 | — |
| SECONDARY Duration of Response (DOR) |
2.89; 1.71 | — |
| SECONDARY Clinical Benefit Rate (CBR) |
73; 88; 58; 75; 75; 75 | — |
| SECONDARY Progression-free Survival (PFS) |
2.79; 3.07; 2.89; 2.6 | — |
| SECONDARY Overall Survival |
4.76; 6.59 | — |
| SECONDARY Maximum Serum Concentration (Cmax) of Rovalpituzumab Tesirine Antibody Drug Conjugate (ADC) |
1.27; 2.42; 5.08; 8.81; 18.8; 11.4 | — |
| SECONDARY Area Under the Serum Concentration-time Curve (AUC) of Rovalpituzumab Tesirine ADC |
12.3; 26.3; 45.6; 97.3; 142; 107 | — |
Summary
The purpose of this study is to assess the safety and tolerability of rovalpituzumab tesirine (SC16LD6.5) at different dose levels in patients with small cell lung cancer whose cancer has progressed or recurred following standard chemotherapy. Once a safe and tolerable dose is determined, the anti-cancer activity of SC16LD6.5 will be assessed by measuring the extent of tumor shrinkage. SC16LD6.5 is an antibody-drug conjugate (ADC). The antibody (SC16) targets a protein that appears to be expressed on the surface of most small cell lung cancers that have been assessed using an immunohistochemical assay. The drug, D6.5, is a very potent form of chemotherapy, specifically a DNA-damaging agent, that is cell cycle independent. ADC's theoretically provide more precise delivery of chemotherapy to cancer cells, possibly improving effectiveness relative to toxicities.
Eligibility Criteria
Inclusion Criteria
- Provision of informed consent
- Male or female ≥18 years of age
- Histologic or cytologic confirmed diagnosis of small cell lung cancer, either limited or extensive disease at initial presentation is allowed
- Evidence of progressive disease during or following 1 or 2 prior chemotherapy regimens
- At least 1 prior regimen must have contained a platinum salt
- 'Adjuvant therapy' will constitute a prior treatment regimen
- No more than 2 prior regimens are allowed
- Measurable disease (only for the phase II portion)
- Eastern Cooperative Oncology Group (ECOG) Performance status 0-1
- A minimum life expectancy of 12 weeks
- Adequate bone marrow, hepatic and renal function as evidenced by:
- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L
- Platelet count ≥ 100 x 109/L
- Hemoglobin ≥ 9.0 g/dL
- Serum bilirubin 450 msec (males) or >470 msec (females)
Data sourced from ClinicalTrials.gov (NCT01901653). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.