Evidence map›Paper›PMID 26098748›Full record

Trial reportJournal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer2015

Safety and Efficacy of Buparlisib (BKM120) in Patients with PI3K Pathway-Activated Non-Small Cell Lung Cancer: Results from the Phase II BASALT-1 Study.

Johan F Vansteenkiste, Jean-Luc Canon, Filippo De Braud, Francesco Grossi, Tommaso De Pas, Jhanelle E Gray, Wu-Chou Su, Enriqueta Felip, Hiroshige Yoshioka, Cesare Gridelli and 9 more

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 100 papers.

0numbers the graph read from it
0cells of the map it votes in
100citing papers in PubMed
15.8field-weighted citation impact, top 1% 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.

NCT01297491 phase2completednot on this map

An Open Label Two-stage Study of Orally Administered BKM120 in Patients With Metastatic Non-small Cell Lung Cancer With Activated PI3K Pathway

TypeinterventionalSponsorNovartis PharmaceuticalsRan2011 to 2014Enrolled63ConditionsNon-small Cell Lung CancerArmsBKM120
NCT01820325 phase1terminatednot on this map

A Dose-finding Phase Ib Study Followed by a Randomized, Double-blind Phase II Study of Carboplatin and Paclitaxel With or Without Buparlisib in Patients With Previously Untreated Metastatic Non-small Cell Lung Cancer (NSCLC) of Squamous Histology

TypeinterventionalSponsorNovartis PharmaceuticalsRan2013 to 2014Enrolled6ConditionsNon-Small Cell Lunch CancerArmsBuparlisib, Buparlisib placebo, Carboplatin, Paclitaxel
3 · Its place in the literature

Who cites it

100 citing papers in PubMed, 160 citations in OpenAlex.

  1. Phase II study of BKM120 in patients with advanced esophageal squamous cell carcinoma (EPOC1303).Esophagus : official journal of the Japan Esophageal Society · 2022
    Trial
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  8. Biomedicines · 2026
    Article
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  12. Review
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  17. Targeting KRASDrugs · 2024
    Review
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40 more citing papers are in PubMed but not listed here.

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

19 authors at 17 institutions in 10 countries.

Johan F VansteenkisteUniversity Hospitals KU Leuven, Leuven, Belgium. Electronic address: johan.vansteenkiste@uzleuven.be.
Jean-Luc CanonGrand Hôpital de Charleroi, Charleroi, Belgium.
Filippo De BraudFondazione IRCCS, Istituto Nazionale dei Tumori, Milan, Italy.
Francesco GrossiAOU San Martino IST, Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy.
Tommaso De PasEuropean Institute of Oncology, Milan, Italy.
Jhanelle E GrayMoffitt Cancer Center, Tampa, Florida.
Wu-Chou SuNational Cheng Kung University Hospital, Tainan, Taiwan.
Enriqueta FelipMedical Oncology Department, Vall d'Hebron University Hospital, Vall d'Hebron Institute of Oncology (VHIO), Barcelona, Spain.
Hiroshige YoshiokaKurashiki Central Hospital, Kurashiki, Japan.
Cesare GridelliS.G. Moscati Hospital, Avellino, Italy.
Grace K DyRoswell Park Cancer Institute, Buffalo, New York.
Sumitra ThongprasertChiang Mai University, Chiang Mai, Thailand.
Martin ReckLungenClinic Grosshansdorf, Airway Research Center North (ARCN), German Center for Lung Research (DZL), Grosshansdorf, Germany.
Paola AimoneNovartis Pharma AG, Basel, Switzerland.
Gena Atalla VidamNovartis Pharmaceuticals Corporation, East Hanover, New Jersey.
Pantelia RoussouNovartis Pharma AG, Basel, Switzerland.
Ying A WangNovartis Institutes for BioMedical Research, Cambridge, Massachusetts.
Emmanuelle Di TomasoNovartis Institutes for BioMedical Research, Cambridge, Massachusetts.
Jean-Charles SoriaGustave Roussy Cancer Campus and University Paris-Sud, Villejuif, France.
Novartis (Switzerland) · CHNovartis (United States) · USAlleanza Contro il Cancro · ITAzienda Ospedaliera S.Giuseppe Moscati · ITBoston Biomedical Research Institute · USChiang Mai University · THEuropean Institute of Oncology · ITFondazione IRCCS Istituto Nazionale dei Tumori · ITGerman Center for Lung Research · DEGrand Charleroi Hospital · BEInstitut Gustave Roussy · FRKU Leuven · BEKurashiki Central Hospital · JPMoffitt Cancer Center · USNational Cheng Kung University Hospital · TWRoswell Park Comprehensive Cancer Center · USVall d'Hebron Institute of Oncology

Funding

TRANSLATIONAL RESEARCHP30CA076292 · NCI · UNIVERSITY OF SOUTH FLORIDA · PI KENNETH Lynn WRIGHT · 1998 to 2026
$93.5M
Integrative Molecular Epidemiology WorkshopR25CA174664 · NCI · AMERICAN ASSOCIATION FOR CANCER RESEARCH · PI Shelley S Tworoger · 2013 to 2026
$2.8M
NCI NIH HHS P30 CA076292NCI NIH HHS R25 CA174664
6 · The paper itself

Abstract

introductionThe phosphatidylinositol 3-kinase (PI3K) pathway promotes tumor growth and treatment resistance in non-small cell lung cancer (NSCLC). The aim of the open-label, two-stage, Phase II study BASALT-1 (NCT01820325) was to investigate the pan-PI3K inhibitor buparlisib (BKM120) in patients with PI3K pathway-activated, relapsed NSCLC.

methodsAfter prescreening for PI3K pathway activation, patients with PI3K pathway-activated, metastatic, squamous or nonsquamous NSCLC, who had relapsed after prior systemic antineoplastic therapy, were enrolled. In Stage 1, patients received single-agent buparlisib (100 mg/day). A futility analysis was performed independently in each histology group, based on the 12-week progression-free survival rate for the first 30 patients treated in each group being less than 50%. Exploratory biomarker analyses were performed in archival tissue samples and circulating tumor DNA (ctDNA).

resultsOf 1242 prescreened patients, 13.5% exhibited PI3K pathway activation. As of June 5, 2014, 63 patients (30 squamous and 33 nonsquamous) were treated in Stage 1. The 12-week progression-free survival rates were 23.3% (95% confidence interval: 9.9-42.3) and 20.0% (95% confidence interval: 7.7-38.6) in the squamous and nonsquamous groups, respectively. Stage 2 was therefore not initiated in either group. PI3K pathway mutations in ctDNA were more concordant with metastatic tissue than with primary biopsies.

conclusionsDespite preselecting patients for targeted treatment, BASALT-1 did not meet its primary objective during Stage 1. PI3K pathway activation can be detected using ctDNA, but may not be the main oncogenic driver in NSCLC. Combinations of PI3K inhibitors with other agents may demonstrate greater efficacy than monotherapy.

Indexed as

AgedAminopyridinesCarcinoma, Non-Small-Cell LungFemaleHumansLung NeoplasmsMaleMiddle AgedMorpholinesNeoplasm MetastasisPhosphatidylinositol 3-KinasesAminopyridinesMorpholinesNVP-BKM120Phosphatidylinositol 3-Kinases

Identifiers

PMID26098748
PMCPMC4646607
OpenAlexW2238997491

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.