Pembrolizumab in Patients With Metastatic Non-squamous Non-small Cell Lung Cancer

NCT02955758 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: IRB-37785NCI-2016-01311LUN0085
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial studies how well pembrolizumab works in treating patients with non-squamous non-small cell lung cancer which has spread to other places in the body. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread.

Conditions

Metastatic Non-Squamous Non-Small Cell Lung Carcinoma

Outcome Measures

Primary Outcomes (1)

• Correlation of Tumor-informed CAPP-Seq ctDNA Analysis With Radiologic Tumor Assessments

  Circulating tumor DNA (ctDNA) levels will be measured using Cancer personalized profiling by deep sequencing (CAPP Seq) with radiographic tumor assessments using RECIST v1.1 criteria in patients with metastatic NSCLC treated with pembrolizumab. ctDNA will be measured as percentage of total circulating free DNA. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

  Up to 2 years

Secondary Outcomes (4)

• Overall Response Rate (ORR)

  Up to 2 years

• PFS Measured Using RECIST v1.1 Criteria

  From the time of first treatment with pembrolizumab to the time of progression or death from any cause, whichever comes earlier, assessed up to 2 years

• Overall Survival (OS)

  From the time of first treatment with pembrolizumab to the time of death, assessed up to 3 years

• Incidence of Adverse Events Graded According to Common Terminology Criteria for Adverse Events Version 4.03

  Up to 2 years

Study Arms (1)

Treatment (pembrolizumab)

EXPERIMENTAL

Patients receive pembrolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 35 courses in the absence of disease progression or unacceptable toxicity.

Biological: Pembrolizumab

Interventions

Pembrolizumab BIOLOGICAL

Given IV, 200mg fixed dose, every 3 weeks

Also known as: Keytruda, Lambrolizumab, MK-3475, SCH 900475

Treatment (pembrolizumab)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has a pathologically proven recurrent or metastatic non squamous non small cell lung cancer
• (a) Previously received at least one line of prior systemic therapy for metastatic disease.
• i. If the patient has a sensitizing EGFR mutation or ALK rearrangement, the patient must have received at least one prior targeted therapy for metastatic disease (ie, EGFR TKI therapy or ALK TKI therapy, respectively).
• ii. There is no limit on prior therapies allowed. Patients must have completed previous treatment (including other investigational therapy) in greater than or equal to the following times prior to initiation of trial treatment:
• Anti cancer monoclonal antibody (mAb) therapy must be completed ≥ 3 weeks prior to trial treatment
• Chemotherapy administered in a daily or weekly schedule must be completed ≥ 1 week prior to trial treatment
• Chemotherapy administered in an every 2 week schedule must be completed ≥ 2 weeks prior to trial treatment
• Chemotherapy administered in an every 3 week schedule must be completed ≥ 3 weeks prior to trial treatment
• Targeted small molecule therapy must be completed ≥ 1 week prior to trial treatment OR (b) Have not received prior systemic therapy for their cancer in recurrent or metastatic setting, AND have a tumor with Tumor Proportion Score (TPS) ≥ 50% as measured by 22C3 PD L1 IHC test, AND no evidence of a sensitizing EGFR mutation or ALK rearrangement.
• Prior radiation therapy allowed as long as completed in the following times prior to initiation of trial treatment:
• Definitive curative intent radiation ≥ 3 weeks prior to trial treatment
• Palliative body radiation ≥ 1 week prior to trial treatment
• Stereotactic brain radiation ≥ 1 week prior to trial treatment
• Whole brain radiation ≥ 2 weeks prior to trial treatment
• Patients with previously treated (with radiation or surgery) brain metastases that are stable are allowed. Patients with stable or progressing metastases must have metastases ≤ 1.5 cm, be asymptomatic, and either not be on steroids or be on 10 mg prednisone equivalent or less.

You may not qualify if:

• Is currently receiving another investigational therapy
• Has received prior anti PD 1 or anti PD L1 therapy
• Has clinically significant toxicities from previous anti cancer therapy that have not resolved, or have not stabilized at a new baseline
• Has undergone a surgical procedure involving general anesthesia within 2 weeks of starting trial treatment, or has inadequate healing or recovery from complications of surgery prior to starting trial treatment. This does not apply to low risk procedures such as thoracentesis; paracentesis; chest tube/PleurX catheter placement; line placement; needle biopsy of tumor; and bronchoscopy.
• Is receiving high dose systemic steroid therapy within 3 days of trial treatment. Topical and intraarticular steroid injections are allowed, as are physiologic doses of systemic steroids (≤ 10 mg of prednisone equivalent daily).
• Has carcinomatous meningitis as determined by positive CSF cytology
• Has known active additional malignancy that is undergoing active treatment.
• Has active autoimmune disease that has required systemic treatment in the past 2 years (ie, with use of disease modifying agents, supra physiologic doses of systemic corticosteroids or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin; or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Asthma; type I diabetes mellitus; hypothyroidism; and vitiligo are allowed.
• Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating investigator. This includes known active tuberculosis; Grade 3 active infection; history of allogeneic bone marrow transplant or solid organ transplant; known history of Human Immunodeficiency Virus (HIV); known active Hepatitis B (eg, Hep B DNA positive in prior 3 months) or known active Hepatitis C (eg, HCV RNA \[qualitative\] is detected in prior 3 months).
• Known active interstitial lung disease, or current (non infectious) pneumonitis or history of (non infectious) pneumonitis that required oral steroids.
• Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting

Sponsors & Collaborators

• Joel Neal: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Stanford University, School of Medicine

Palo Alto, California, 94304, United States

Location

MeSH Terms

Interventions

pembrolizumab

Results Point of Contact

• Title: Dr. Joel W. Neal
• Organization: Stanford University

jwneal@stanford.edu

(650) 498-6000

Study Officials

• Joel Neal

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: November 3, 2016
• First Posted: November 4, 2016
• Study Start: October 1, 2016
• Primary Completion: April 9, 2024
• Study Completion: April 9, 2024
• Last Updated: October 9, 2024
• Results First Posted: October 9, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)