Evidence map›Paper›PMID 37129455›Full record

ArticleThe oncologist2023

A Phase Ib Dose-Escalation Study of LCL161 Plus Oral Topotecan for Patients With Relapsed/Refractory Small Cell Lung Cancer and Select Gynecologic Malignancies.

Melissa L Johnson, Manish R Patel, Raid Aljumaily, Suzanne F Jones, Howard A Burris Iii, David R Spigel

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IMulticenter Study
In one paragraph

Article in The oncologist, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02649673 (Phase Ib Dose-Escalation Study of LCL161 in Combination With Oral Topotecan for Patients With Relapsed/Refractory Small Cell Lung Cancer), which is not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
2.5field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02649673 phase1terminatednot on this map

Phase Ib Dose-Escalation Study of LCL161 in Combination With Oral Topotecan for Patients With Relapsed/Refractory Small Cell Lung Cancer (SCLC) and Select Gynecologic Malignancies

TypeinterventionalSponsorSCRI Development Innovations, LLCRan2016 to 2021Enrolled34ConditionsSmall Cell Lung Cancer, Ovarian CancerArmsLCL161, Topotecan, Pegylated GCSF (PEG-GCSF)
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 11 citations in OpenAlex.

  1. Review
  2. Article
  3. Review
  4. Article
  5. Role of Ubiquitin-regulated EMT in Cancer Metastasis and Chemoresistance.International journal of biological sciences · 2025
    Review
  6. Article
  7. Article
  8. Review
  9. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 3 institutions in 1 country.

Melissa L JohnsonSarah Cannon Research Institute, Nashville, TN, USA.
Manish R PatelSarah Cannon Research Institute, Nashville, TN, USA.
Raid AljumailySarah Cannon Research Institute, Nashville, TN, USA.
Suzanne F JonesSarah Cannon Research Institute, Nashville, TN, USA.
Howard A Burris IiiSarah Cannon Research Institute, Nashville, TN, USA.
David R SpigelSarah Cannon Research Institute, Nashville, TN, USA.
Sarah Cannon · USTennessee Oncology · USUniversity of Oklahoma Health Sciences Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis was an open-label, multicenter, single-arm phase Ib dose-escalation study of oral LCL161 administered in combination with oral topotecan in patients with relapsed/refractory small cell lung cancer (SCLC) and select gynecological cancers.

methodsCohorts of 3-6 patients initiated treatment with LCL161 and topotecan in escalating doses. LCL161 was administered orally on days 1, 8, and 15 of each 21-day cycle; topotecan was administered orally for the first 5 days of each 21-day cycle.

resultsA total of 35 patients were enrolled in 6 cohorts; 30 patients were female; 4 patients had SCLC and 19 patients had ovarian cancer. Median prior lines of therapy were 3 (1-10). Median duration of treatment was 7.1 weeks (0.1-174). The most frequent grade 3/4 treatment-related adverse events were thrombocytopenia (51.43%) and anemia (31.43%). ORR was 9.7%; 58% of patients had SD. The study was stopped early before the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) were determined.

conclusionThe addition of LCL161 to oral topotecan caused more myelosuppression when dosed together than what was associated with either drug alone. Moreover, the drug combination did not improve outcomes. The study was terminated early (ClinicalTrials.gov Identifier: NCT02649673).

Indexed as

Genital Neoplasms, FemaleLung NeoplasmsSmall Cell Lung CarcinomaAntineoplastic Combined Chemotherapy ProtocolsFemaleHumansMaleNeoplasm Recurrence, LocalThiazolesTopotecanLCL161ThiazolesTopotecangynecologic malignanciesrelapsed/refractory diseaseSmac mimeticsmall cell lung cancertopotecan

Identifiers

PMID37129455
PMCPMC10322128
OpenAlexW4367668601

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.