(Q26865266)

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Consensus report of a joint NCI thoracic malignancies steering committee: FDA workshop on strategies for integrating biomarkers into clinical development of new therapies for lung cancer leading to the inception of "master protocols" in lung cancer

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scholarly article

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Consensus report of a joint NCI thoracic malignancies steering committee: FDA workshop on strategies for integrating biomarkers into clinical development of new therapies for lung cancer leading to the inception of "master protocols" in lung cancer (English)

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3 April 2019

19 June 2019

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7 August 2019

10

object named as

Fred R. Hirsch

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author name string

Shakun M. Malik

1

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Richard Pazdur

2

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Jeffrey S. Abrams

3

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Mark A. Socinski

4

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William T. Sause

5

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David H. Harpole

6

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John J. Welch

7

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Edward L. Korn

8

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Claudio Dansky Ullmann

9

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language of work or name

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publication date

October 2014

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1 October 2014

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3 April 2019

19 June 2019

7 August 2019

Journal of Thoracic Oncology

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3 April 2019

19 June 2019

7 August 2019

9

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10

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1443-8

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Crizotinib versus chemotherapy in advanced ALK-positive lung cancer.

1 reference

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21 March 2017

Exon 19 deletion mutations of epidermal growth factor receptor are associated with prolonged survival in non-small cell lung cancer patients treated with gefitinib or erlotinib

1 reference

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21 March 2017

Gefitinib or carboplatin-paclitaxel in pulmonary adenocarcinoma

1 reference

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21 March 2017

I-SPY 2: an adaptive breast cancer trial design in the setting of neoadjuvant chemotherapy

1 reference

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21 March 2017

Paclitaxel-carboplatin alone or with bevacizumab for non-small-cell lung cancer

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4165474

21 March 2017

Erlotinib in previously treated non-small-cell lung cancer

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4165474

7 April 2017

Erlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer (OPTIMAL, CTONG-0802): a multicentre, open-label, randomised, phase 3 study

1 reference

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7 April 2017

Gefitinib plus best supportive care in previously treated patients with refractory advanced non-small-cell lung cancer: results from a randomised, placebo-controlled, multicentre study (Iressa Survival Evaluation in Lung Cancer)

1 reference

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7 April 2017

Biomarker enrichment strategies: matching trial design to biomarker credentials

1 reference

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28 September 2017

Statistical and practical considerations for clinical evaluation of predictive biomarkers

1 reference

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28 September 2017

The BATTLE trial: personalizing therapy for lung cancer

1 reference

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28 September 2017

Overall survival as the outcome for randomized clinical trials with effective subsequent therapies

1 reference

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28 September 2017

Outcome--adaptive randomization: is it useful?

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4165474

28 September 2017

Randomized clinical trials with biomarkers: design issues

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4165474

28 September 2017

Sources of bias in specimens for research about molecular markers for cancer

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4165474

28 September 2017

Use of archived specimens in evaluation of prognostic and predictive biomarkers

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4165474

28 September 2017

Clinical trial designs for predictive biomarker validation: theoretical considerations and practical challenges.

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4165474

28 September 2017

Epidermal growth factor receptor mutations in patients with non-small cell lung cancer

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4165474

28 September 2017

Food and Drug Administration regulation of in vitro diagnostic devices

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4165474

28 September 2017

Efficacy of gefitinib, an inhibitor of the epidermal growth factor receptor tyrosine kinase, in symptomatic patients with non-small cell lung cancer: a randomized trial

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4165474

28 September 2017

Randomized phase III clinical trial designs for targeted agents

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4165474

31 May 2018

Chipping away at the lung cancer genome.

1 reference

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28 November 2018

Rationale for treatment and study design of tailor: a randomized phase III trial of second-line erlotinib versus docetaxel in the treatment of patients affected by advanced non-small-cell lung cancer with the absence of epidermal growth factor recep

1 reference

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28 November 2018

Rapidly rising clinical trial costs worry researchers

1 reference

https://eutils.ncbi.nlm.nih.gov/entrez/eutils/elink.fcgi?dbfrom=pmc&linkname=pmc_refs_pubmed&retmode=json&id=4165474

28 November 2018

FDA perspective on companion diagnostics: an evolving paradigm

1 reference

https://pubmed.ncbi.nlm.nih.gov/25521397

12 December 2020

based on heuristic

inferred from PubMed ID database lookup

Why do phase III clinical trials in oncology fail so often?

1 reference

https://pubmed.ncbi.nlm.nih.gov/25521397

12 December 2020

based on heuristic

inferred from PubMed ID database lookup

The cross-validated adaptive signature design

1 reference

https://pubmed.ncbi.nlm.nih.gov/25521397

12 December 2020

based on heuristic

inferred from PubMed ID database lookup

Customizing Cisplatin Based on Quantitative Excision Repair Cross-Complementing 1 mRNA Expression: A Phase III Trial in Non–Small-Cell Lung Cancer

1 reference

https://pubmed.ncbi.nlm.nih.gov/25521397

12 December 2020

based on heuristic

inferred from PubMed ID database lookup

Identifiers

10.1097/JTO.0000000000000314

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PMC publication ID

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PubMed publication ID

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