Sculptor Study Begins Enrolling Patients With Small Cell Lung Cancer

Patients with small cell lung cancer will receive diagnostic and post-progression tumor tissue profiling, plasma ctDNA biomarker profiling, standard of care therapy, and disease surveillance in the Sculptor study.

The prospective Sculptor study (NCT05257551), which explores and identifies biomarkers of response in patients with small cell lung cancer (SCLC), is open for enrollment, according to Tempus.1

To support this early research, the study, which is a collaboration between Tempus and AstraZeneca, is using a comprehensive portfolio of molecular profiling offerings. The goal of the trial is to identify distinct segments that may benefit from emerging therapies, or a treatable target from which to develop an associated therapy to treat patients with SCLC.

“This collaborative study will facilitate the investigation of SCLC patient populations to provide us with key insights in hopes of enabling pharmaceutical solutions that increase the overall survival of this disease,” said Kate Sasser, PhD, chief scientific officer at Tempus. “This type of early-stage, prospective study is only possible when combining Tempus’s comprehensive sequencing capabilities, multimodal database, and just-in-time clinical trial network.”

Lung cancer is the second most common cancer in the United States and approximately 13% of those diagnosed have SCLC, according to the American Cancer Society. The aggressive disease is characterized by rapid growth, early metastasis, and acquired therapeutic resistance. A high unmet need for therapeutic targets and treatments exist in this space and to date, there are limited ways to stratify this specific patient population.

The Sculptor study is a non-interventional trial evaluating approximately 50 patients with SCLC. Those enrolled will receive diagnostic and, if possible, post-progression tumor tissue profiling, as well as plasma ctDNA biomarker profiling on top of their standard of care therapy and disease surveillance.2

Patients aged 18 years and older with SCLC will be included if their diagnosis is made with an excisional or core needle biopsy specimen, they have extensive stage disease at time of diagnosis, and submit a fresh or archived formalin-fixed paraffin-embedded tumor sample to the central laboratory. Further, patients must have an ECOG performance status of 0 or 1 and plan extensive stage first-line therapy of etoposide, carboplatin, and a PD-L1 inhibitor.

For primary end points, investigators will determine if tumor tissue transcriptional subtypes can be detected and will characterize relationships between tissue transcriptional subtype and clinical outcomes. Secondary end points include assessing the potential for liquid biopsy in SCLC and testing which tissue and sample variables confound gene expression subtypes.

Other end points of the trial include measuring biomarkers of SCLC using the TEMPUS xT assay, identifying biomarkers and mechanisms of progression, and studying progression-free survival and overall survival.

The study is currently active at 5 sites with plans to expand to additional locations across the country in order to allow the dataset to be representative of the overall SCLC patient population in the United States.

“We are excited to announce commencement of the first clinical trial stemming from our strategic collaboration with Tempus,” said Cristian Massacesi, chief medical officer & oncology chief development officer of AstraZeneca, in the press release. “AstraZeneca’s investigation of novel therapies for SCLC sub-populations is another example of our precision medicine approach and mission to put patients first and follow the science.”

REFERENCES:
  1. Tempus announces prospective study for biomarker discovery in small cell lung cancer. News release. Tempus. Accessed January 5, 2023. January 5, 2023.
  2. Tempus sculptor study: small cell lung cancer (SCLC) observational study. ClinicalTrials.gov. Updated December 21, 2022. Accessed January 5, 2022. https://clinicaltrials.gov/ct2/show/NCT05257551